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68Ga-OPS202 Study for Diagnostic Imaging of GEP NET

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162446
Recruitment Status : Completed
First Posted : June 12, 2014
Results First Posted : October 2, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Gastroenteropancreatic Neuroendocrine Tumors
Intervention Drug: satoreotide trizoxetan
Enrollment 12
Recruitment Details This open-label, micro-dosing study with 2 sequentially ascending single peptide doses was conducted in a single study center in Switzerland between 23 June 2014 and 14 January 2015.
Pre-assignment Details A total of 12 participants with histologically confirmed gastro-entero-pancreatic neuroendocrine tumors (GEP NET) and a previously performed somatostatin receptor scan were treated in this study. Each participant underwent a screening visit within 28 days prior to receiving the study’s investigational product (IP).
Arm/Group Title All Participants
Hide Arm/Group Description Participants received a single dose of the OPS202 peptide (15 [± 5] microgram (μg) on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 megabecquerel (MBq) (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to three dimensional (3D) positron emission tomography/computed tomography (PET/CT) scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title All Participants
Hide Arm/Group Description Participants received a single dose of the OPS202 peptide (15 [± 5] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
Safety analysis set (SAF) included all participants of the full analysis set (FAS) who received the IP, regardless of any protocol deviations.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
54.8  (14.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
5
  41.7%
Male
7
  58.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
11
  91.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs)
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a IP and which does not necessarily have a causal relationship with this treatment. For this study, all AEs were regarded as 'treatment emergent', i.e., not seen before administration of the IP or, if already present before administration, worsened after start of administration. An SAE was defined as an event that led to death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect. An ADR was defined as an AE with probable, possible or unlikely relationship to the administration of 68Ga-OPS202.
Time Frame From start of IP administration to end of the study visit (approximately 28 to 36 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The SAF included all participants of the FAS who received the IP, regardless of any protocol deviations.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants received a single dose of the OPS202 peptide (15 [± 5] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE 6
SAEs 0
ADRs 5
2.Primary Outcome
Title Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication
Hide Description Laboratory assessments included hematology, blood biochemistry and urine analysis. Vital signs included systolic and diastolic blood pressure, heart rate and axillary body temperature. Cardiac safety was assessed by 12-lead ECGs and physical examination included general appearance, head, neck, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal, neurological, endocrine, lymphatic, dermatological, psychological/psychiatric, abdomen, and genitourinary body systems. All medications (including herbal products) taken from visit 1 (Day 0) to visit 3 (7-15 days after visit 2 (3-4 weeks after visit 1), end of the study) were recorded in the participant's case report form.
Time Frame From start of IP administration to end of the study visit (approximately 28 to 36 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The SAF included all participants of the FAS who received the investigational product, regardless of any protocol deviations.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants received a single dose of the OPS202 peptide (15 [± 5] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
Laboratory parameters abnormalities 8
Vital sign abnormalities 7
12-Lead ECG abnormalities 1
Physical examination abnormalities 9
Concomitant medications required 12
3.Secondary Outcome
Title Number of Malignant and Benign Lesions Detected for Session 1
Hide Description At visit 1, after administration of 15 μg 68Ga-OPS202, a dynamic scan was performed in kidney region over first 30 minutes; static scans were performed from head to sub-inguinal region at 0.5, 1, 2 and 4 h post-injection. At visit 2, after administration of 50 μg 68Ga-OPS202, a static scan was performed from head to sub-inguinal region at 1 h post-injection. A previous somatostatin receptor scan had been performed within 6 months prior to Day 0. Lesions were classified into malignant and benign by readers. Lesion matching was performed between somatostatin receptor scan and 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. Number of lesions for each organ/tissue and overall were calculated and absolute numbers reported. Two different read sessions were held to generate data sets for evaluation of target variables. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.
Time Frame 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The Intention-to-Treat (ITT) set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
Arm/Group Title ITT Population (Pre-dose) ITT Population (Day 0) ITT Population (Day 21)
Hide Arm/Group Description:
Participants had a somatostatin receptor scan performed within 6 months prior to the first injection of IP.
Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.
Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Overall Number of Participants Analyzed 12 12 12
Mean (Standard Deviation)
Unit of Measure: lesion
Malignant: Total Number Analyzed 11 participants 11 participants 11 participants
9.3  (10.49) 17.0  (17.31) 20.1  (20.58)
Malignant: Bone Number Analyzed 2 participants 2 participants 2 participants
1.0  (0.00) 1.0  (0.00) 1.0  (0.00)
Malignant: Liver Number Analyzed 9 participants 9 participants 9 participants
8.6  (10.62) 17.4  (17.98) 21.7  (20.86)
Malignant: Lymph node Number Analyzed 8 participants 8 participants 8 participants
2.5  (2.56) 2.9  (2.10) 2.5  (2.27)
Malignant: Peritoneum Number Analyzed 1 participants 1 participants 1 participants
1.0 [1]   (NA) 1.0 [1]   (NA) 1.0 [1]   (NA)
Malignant: Small bowel Number Analyzed 2 participants 2 participants 2 participants
1.0  (0.00) 2.0  (1.41) 1.5  (0.71)
Benign: Total Number Analyzed 4 participants 4 participants 4 participants
3.0  (1.83) 1.8  (2.87) 3.0  (3.16)
Benign: Lung Number Analyzed 1 participants 1 participants 1 participants
0.0 [1]   (NA) 2.0 [1]   (NA) 3.0 [1]   (NA)
Benign: Lymph node Number Analyzed 1 participants 1 participants 1 participants
1.0 [1]   (NA) 0.0 [1]   (NA) 0.0 [1]   (NA)
Benign: Mamma Number Analyzed 1 participants 1 participants 1 participants
2.0 [1]   (NA) 2.0 [1]   (NA) 2.0 [1]   (NA)
Benign: Mediastinum Number Analyzed 1 participants 1 participants 1 participants
1.0 [1]   (NA) 0.0 [1]   (NA) 0.0 [1]   (NA)
Benign: Pancreas Number Analyzed 1 participants 1 participants 1 participants
1.0 [1]   (NA) 1.0 [1]   (NA) 1.0 [1]   (NA)
Benign: Small bowel Number Analyzed 1 participants 1 participants 1 participants
4.0 [1]   (NA) 0.0 [1]   (NA) 4.0 [1]   (NA)
Benign: Spleen Number Analyzed 1 participants 1 participants 1 participants
1.0 [1]   (NA) 1.0 [1]   (NA) 1.0 [1]   (NA)
Benign: Stomach Number Analyzed 1 participants 1 participants 1 participants
1.0 [1]   (NA) 1.0 [1]   (NA) 1.0 [1]   (NA)
Benign: Thyroid gland Number Analyzed 1 participants 1 participants 1 participants
1.0 [1]   (NA) 0.0 [1]   (NA) 0.0 [1]   (NA)
[1]
Standard deviation cannot be calculated when only one participant analyzed.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 0)
Comments Comparison of malignant lesions in total tissues between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 21)
Comments Comparison of malignant lesions in total tissues between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 0)
Comments Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 21)
Comments Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 0)
Comments Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.500
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 21)
Comments Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding
Hide Description Tumor contrast in PET imaging was determined by qualitative visual analysis. 68Ga-OPS202 binding was present if at least one lesion, regardless of nature, was detected within respective tissue location. Percentages were based on number of participants with available scan at corresponding time point.
Time Frame At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
Arm/Group Title ITT Population (Day 0) ITT Population (Day 21)
Hide Arm/Group Description:
Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.
Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: percentage of participants
Total: At 0.5 hour Number Analyzed 12 participants 0 participants
100
Total: At 1 hour Number Analyzed 12 participants 12 participants
100 100
Total: At 2 hour Number Analyzed 12 participants 0 participants
100
Total: At 4 hour Number Analyzed 12 participants 0 participants
100
Bone: At 0.5 hour Number Analyzed 12 participants 0 participants
16.7
Bone: At 1 hour Number Analyzed 12 participants 12 participants
16.7 16.7
Bone: At 2 hour Number Analyzed 12 participants 0 participants
16.7
Bone: At 4 hour Number Analyzed 12 participants 0 participants
16.7
Liver: At 0.5 hour Number Analyzed 12 participants 0 participants
75.0
Liver: At 1 hour Number Analyzed 12 participants 12 participants
75.0 75.0
Liver: At 2 hour Number Analyzed 12 participants 0 participants
75.0
Liver: At 4 hour Number Analyzed 12 participants 0 participants
75.0
Lung: At 0.5 hour Number Analyzed 12 participants 0 participants
0
Lung: At 1 hour Number Analyzed 12 participants 12 participants
0 0
Lung: At 2 hour Number Analyzed 12 participants 0 participants
0
Lung: At 4 hour Number Analyzed 12 participants 0 participants
0
Lymph node: At 0.5 hour Number Analyzed 12 participants 0 participants
58.3
Lymph node: At 1 hour Number Analyzed 12 participants 12 participants
58.3 58.3
Lymph node: At 2 hour Number Analyzed 12 participants 0 participants
58.3
Lymph node: At 4 hour Number Analyzed 12 participants 0 participants
58.3
Mamma: At 0.5 hour Number Analyzed 12 participants 0 participants
0
Mamma: At 1 hour Number Analyzed 12 participants 12 participants
0 0
Mamma: At 2 hour Number Analyzed 12 participants 0 participants
0
Mamma: At 4 hour Number Analyzed 12 participants 0 participants
0
Pancreas: At 0.5 hour Number Analyzed 12 participants 0 participants
8.3
Pancreas: At 1 hour Number Analyzed 12 participants 12 participants
8.3 8.3
Pancreas: At 2 hour Number Analyzed 12 participants 0 participants
8.3
Pancreas: At 4 hour Number Analyzed 12 participants 0 participants
8.3
Peritoneum: At 0.5 hour Number Analyzed 12 participants 0 participants
8.3
Peritoneum: At 1 hour Number Analyzed 12 participants 12 participants
8.3 8.3
Peritoneum: At 2 hour Number Analyzed 12 participants 0 participants
8.3
Peritoneum: At 4 hour Number Analyzed 12 participants 0 participants
8.3
Small bowel: At 0.5 hour Number Analyzed 12 participants 0 participants
25.0
Small bowel: At 1 hour Number Analyzed 12 participants 12 participants
25.0 25.0
Small bowel: At 2 hour Number Analyzed 12 participants 0 participants
25.0
Small bowel: At 4 hour Number Analyzed 12 participants 0 participants
16.7
Thyroid gland: At 0.5 hour Number Analyzed 12 participants 0 participants
0
Thyroid gland: At 1 hour Number Analyzed 12 participants 12 participants
0 0
Thyroid gland: At 2 hour Number Analyzed 12 participants 0 participants
0
Thyroid gland: At 4 hour Number Analyzed 12 participants 0 participants
0
5.Secondary Outcome
Title Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1
Hide Description At visit 1, after administration of 15 μg 68Ga-OPS202, a dynamic scan was performed in kidney region over the first 30 minutes (0-0.5 h); static scans were performed from head to sub-inguinal region at 0.5, 1, 2 and 4 h post-injection. At visit 2, after administration of 50 μg 68Ga-OPS202, a static scan was performed from head to sub-inguinal region at 1 h post-injection. A previous somatostatin receptor scan had been performed within 6 months prior to Day 0. Lesions were classified into malignant and benign lesion by the readers according to their experience. Lesion matching was performed between the somatostatin receptor scan and the 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. The mean SUVmax of lesions (mean of all identified lesions in the lymph node and liver) was summarized by nature of the lesions (malignant, benign). Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.
Time Frame 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
Arm/Group Title ITT Population (Pre-dose) ITT Population (Day 0) ITT Population (Day 21)
Hide Arm/Group Description:
Participants had a somatostatin receptor scan performed within 6 months prior to the first injection of IP.
Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.
Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Overall Number of Participants Analyzed 12 12 12
Mean (Standard Deviation)
Unit of Measure: SUVmax
Malignant: Bone Number Analyzed 2 participants 2 participants 2 participants
4.394  (0.9396) 4.153  (2.0270) 4.455  (0.2425)
Malignant: Liver Number Analyzed 9 participants 9 participants 9 participants
12.135  (4.4660) 10.468  (4.7970) 8.458  (3.4840)
Malignant: Lymph node Number Analyzed 7 participants 8 participants 8 participants
15.192  (7.4318) 16.289  (12.0091) 14.602  (10.9725)
Malignant: Peritoneum Number Analyzed 1 participants 1 participants 1 participants
6.579 [1]   (NA) 6.740 [1]   (NA) 9.504 [1]   (NA)
Malignant: Small bowel Number Analyzed 2 participants 2 participants 2 participants
14.049  (0.2124) 11.140  (7.9828) 9.156  (1.0674)
Benign: Lung Number Analyzed 0 participants 1 participants 1 participants
3.410 [1]   (NA) 3.131 [1]   (NA)
Benign: Lymph node Number Analyzed 1 participants 0 participants 0 participants
3.093 [1]   (NA)
Benign: Mamma Number Analyzed 1 participants 1 participants 1 participants
2.353 [1]   (NA) 2.907 [1]   (NA) 2.538 [1]   (NA)
Benign: Mediastinum Number Analyzed 1 participants 0 participants 0 participants
2.242 [1]   (NA)
Benign: Pancreas Number Analyzed 1 participants 1 participants 1 participants
14.086 [1]   (NA) 8.693 [1]   (NA) 6.659 [1]   (NA)
Benign: Small bowel Number Analyzed 1 participants 0 participants 1 participants
8.264 [1]   (NA) 4.990 [1]   (NA)
Benign: Spleen Number Analyzed 1 participants 1 participants 1 participants
16.343 [1]   (NA) 15.997 [1]   (NA) 14.308 [1]   (NA)
Benign: Stomach Number Analyzed 1 participants 1 participants 1 participants
6.713 [1]   (NA) 7.630 [1]   (NA) 5.305 [1]   (NA)
Benign: Thyroid gland Number Analyzed 1 participants 0 participants 0 participants
3.768 [1]   (NA)
[1]
Standard deviation cannot be calculated when only one participant analyzed.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 0)
Comments Comparison of SUVmax of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.250
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 21)
Comments Comparison of SUVmax of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 0)
Comments Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.688
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 21)
Comments Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.578
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
6.Secondary Outcome
Title Mean SUVmax of Malignant and Benign Lesions for Session 2
Hide Description The mean SUVmax of all identified lesions in the respective organ/tissue was determined. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.
Time Frame At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
Arm/Group Title ITT Population (Day 0) ITT Population (Day 21)
Hide Arm/Group Description:
Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.
Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: SUVmax
Malignant: Bone: At 0.5 hour Number Analyzed 2 participants 0 participants
4.938  (1.1179)
Malignant: Bone: At 1 hour Number Analyzed 2 participants 2 participants
4.153  (2.0270) 4.455  (0.2425)
Malignant: Bone: At 2 hour Number Analyzed 2 participants 0 participants
4.601  (1.3164)
Malignant: Bone: At 4 hour Number Analyzed 2 participants 0 participants
4.564  (1.0832)
Malignant: Liver: At 0.5 hour Number Analyzed 9 participants 0 participants
10.086  (5.0229)
Malignant: Liver: At 1 hour Number Analyzed 9 participants 9 participants
11.485  (6.3691) 9.037  (3.9033)
Malignant: Liver: At 2 hour Number Analyzed 9 participants 0 participants
9.897  (4.3537)
Malignant: Liver: At 4 hour Number Analyzed 9 participants 0 participants
12.482  (5.9410)
Malignant: Lymph node: At 0.5 hour Number Analyzed 7 participants 0 participants
14.581  (9.7609)
Malignant: Lymph node: At 1 hour Number Analyzed 7 participants 7 participants
17.044  (11.6224) 15.836  (10.9868)
Malignant: Lymph node: At 2 hour Number Analyzed 7 participants 0 participants
18.166  (10.6940)
Malignant: Lymph node: At 4 hour Number Analyzed 7 participants 0 participants
17.985  (13.5368)
Malignant: Peritoneum: At 0.5 hour Number Analyzed 1 participants 0 participants
3.293 [1]   (NA)
Malignant: Peritoneum: At 1 hour Number Analyzed 1 participants 1 participants
6.740 [1]   (NA) 9.504 [1]   (NA)
Malignant: Peritoneum: At 2 hour Number Analyzed 1 participants 0 participants
7.484 [1]   (NA)
Malignant: Peritoneum: At 4 hour Number Analyzed 1 participants 0 participants
7.216 [1]   (NA)
Malignant: Small bowel: At 0.5 hour Number Analyzed 3 participants 0 participants
9.474  (5.8641)
Malignant: Small bowel: At 1 hour Number Analyzed 3 participants 3 participants
11.207  (4.5367) 7.440  (2.8588)
Malignant: Small bowel: At 2 hour Number Analyzed 3 participants 0 participants
9.075  (4.9059)
Malignant: Small bowel: At 4 hour Number Analyzed 2 participants 0 participants
14.695  (6.9926)
Benign: Pancreas: At 0.5 hour Number Analyzed 1 participants 0 participants
8.561 [1]   (NA)
Benign: Pancreas: At 1 hour Number Analyzed 1 participants 1 participants
8.512 [1]   (NA) 6.659 [1]   (NA)
Benign: Pancreas: At 2 hour Number Analyzed 1 participants 0 participants
8.734 [1]   (NA)
Benign: Pancreas: At 4 hour Number Analyzed 1 participants 0 participants
5.759 [1]   (NA)
[1]
Standard deviation cannot be calculated when only one participant analyzed.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ITT Population (Day 0), ITT Population (Day 21)
Comments Comparison of SUVmax of malignant lesions in liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ITT Population (Day 0), ITT Population (Day 21)
Comments Comparison of SUVmax of malignant lesions in lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.219
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
7.Secondary Outcome
Title Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1
Time Frame 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
Arm/Group Title ITT Population (Pre-dose) ITT Population (Day 0) ITT Population (Day 21)
Hide Arm/Group Description:
Participants had a somatostatin receptor scan performed within 6 months prior to the first injection of IP.
Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.
Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Overall Number of Participants Analyzed 12 12 12
Mean (Standard Deviation)
Unit of Measure: SUVmax
Bone Number Analyzed 2 participants 2 participants 2 participants
0.610  (0.1801) 0.739  (0.1780) 0.636  (0.1207)
Muscle Number Analyzed 12 participants 12 participants 12 participants
1.020  (0.3141) 0.883  (0.2530) 0.896  (0.1812)
Liver Number Analyzed 12 participants 12 participants 12 participants
6.801  (1.9676) 3.642  (1.6381) 2.959  (0.8089)
Lymph node Number Analyzed 7 participants 8 participants 8 participants
2.229  (1.2017) 1.870  (0.6967) 2.368  (1.7112)
Peritoneum Number Analyzed 1 participants 1 participants 1 participants
0.776 [1]   (NA) 0.927 [1]   (NA) 1.401 [1]   (NA)
Small bowel Number Analyzed 2 participants 2 participants 2 participants
4.180  (0.7893) 2.080  (0.5162) 1.707  (0.0636)
[1]
Standard deviation cannot be calculated when only one participant analyzed.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 0)
Comments Comparison of SUVmax of RT in muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.064
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 21)
Comments Comparison of SUVmax of RT in muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.339
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 0)
Comments Comparison of SUVmax of RT in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 21)
Comments Comparison of SUVmax of RT in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 0)
Comments Comparison of SUVmax of RT in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.297
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 21)
Comments Comparison of SUVmax of RT in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
8.Secondary Outcome
Title Mean SUVmax of RT for Session 2
Hide Description The mean SUVmax of all selected ROIs in the corresponding RT was determined. RTs were determined in tissue locations with malignant lesions only. ROIs were also selected in muscle tissue, which was used as an additional reference region. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.
Time Frame At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
Arm/Group Title ITT Population (Day 0) ITT Population (Day 21)
Hide Arm/Group Description:
Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.
Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: SUVmax
Muscle: At 0.5 hour Number Analyzed 12 participants 0 participants
0.923  (0.2260)
Muscle: At 1 hour Number Analyzed 12 participants 12 participants
0.932  (0.2386) 0.976  (0.2012)
Muscle: At 2 hour Number Analyzed 12 participants 0 participants
1.127  (0.3343)
Muscle: At 4 hour Number Analyzed 12 participants 0 participants
2.013  (0.6884)
Bone: At 0.5 hour Number Analyzed 2 participants 0 participants
0.573  (0.3418)
Bone: At 1 hour Number Analyzed 2 participants 2 participants
0.605  (0.3681) 0.765  (0.1409)
Bone: At 2 hour Number Analyzed 2 participants 0 participants
0.731  (0.0550)
Bone: At 4 hour Number Analyzed 2 participants 0 participants
2.138  (0.7022)
Liver: At 0.5 hour Number Analyzed 12 participants 0 participants
4.201  (1.3697)
Liver: At 1 hour Number Analyzed 12 participants 12 participants
4.040  (1.5213) 3.480  (1.1863)
Liver: At 2 hour Number Analyzed 12 participants 0 participants
4.103  (1.2389)
Liver: At 4 hour Number Analyzed 12 participants 0 participants
6.101  (2.7773)
Lymph node: At 0.5 hour Number Analyzed 7 participants 0 participants
1.723  (0.9118)
Lymph node: At 1 hour Number Analyzed 7 participants 7 participants
2.049  (0.7805) 1.757  (1.1486)
Lymph node: At 2 hour Number Analyzed 7 participants 0 participants
2.467  (1.3033)
Lymph node: At 4 hour Number Analyzed 7 participants 0 participants
1.989  (0.6904)
Peritoneum: At 0.5 hour Number Analyzed 1 participants 0 participants
1.864 [1]   (NA)
Peritoneum: At 1 hour Number Analyzed 1 participants 1 participants
1.038 [1]   (NA) 1.163 [1]   (NA)
Peritoneum: At 2 hour Number Analyzed 1 participants 0 participants
0.856 [1]   (NA)
Peritoneum: At 4 hour Number Analyzed 1 participants 0 participants
1.501 [1]   (NA)
Small bowel: At 0.5 hour Number Analyzed 3 participants 0 participants
2.519  (0.2743)
Small bowel: At 1 hour Number Analyzed 3 participants 3 participants
2.571  (1.0644) 1.608  (0.3677)
Small bowel: At 2 hour Number Analyzed 3 participants 0 participants
2.124  (0.7382)
Small bowel: At 4 hour Number Analyzed 3 participants 0 participants
3.177  (0.7174)
[1]
Standard deviation cannot be calculated when only one participant analyzed.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ITT Population (Day 0), ITT Population (Day 21)
Comments Comparison of SUVmax of RT in muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.470
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ITT Population (Day 0), ITT Population (Day 21)
Comments Comparison of SUVmax of RT in liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.233
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ITT Population (Day 0), ITT Population (Day 21)
Comments Comparison of SUVmax of RT in lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.375
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
9.Secondary Outcome
Title Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1
Hide Description The tumor contrast, i.e. the SUV ratio for tumor (malignant lesion)-to-background (3D-SUV-R) of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RTs. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.
Time Frame 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
Arm/Group Title ITT Population (Pre-dose) ITT Population (Day 0) ITT Population (Day 21)
Hide Arm/Group Description:
Participants had a somatostatin receptor scan performed within 6 months prior to the first injection of IP.
Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.
Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Overall Number of Participants Analyzed 12 12 12
Mean (Standard Deviation)
Unit of Measure: ratio
Bone (RT: Bone) Number Analyzed 2 participants 2 participants 2 participants
7.296  (0.6136) 6.125  (4.2161) 7.167  (1.7409)
Bone (RT: Muscle) Number Analyzed 2 participants 2 participants 2 participants
5.227  (1.7044) 6.091  (2.1353) 5.868  (0.4515)
Liver (RT: Liver) Number Analyzed 9 participants 9 participants 9 participants
2.066  (0.9163) 3.234  (1.8130) 3.215  (1.8160)
Liver (RT: Muscle) Number Analyzed 9 participants 9 participants 9 participants
13.434  (7.3703) 12.605  (7.9383) 10.318  (5.7811)
Lymph node (RT: Lymph node) Number Analyzed 7 participants 8 participants 8 participants
9.548  (7.1592) 9.320  (5.2590) 11.034  (13.3938)
Lymph node (RT: Muscle) Number Analyzed 7 participants 8 participants 8 participants
15.110  (7.4282) 19.861  (16.0492) 18.349  (15.9027)
Peritoneum (RT: Peritoneum) Number Analyzed 1 participants 1 participants 1 participants
8.475 [1]   (NA) 7.268 [1]   (NA) 6.783 [1]   (NA)
Peritoneum (RT: Muscle) Number Analyzed 1 participants 1 participants 1 participants
8.366 [1]   (NA) 9.170 [1]   (NA) 11.399 [1]   (NA)
Small bowel (RT: Small bowel) Number Analyzed 2 participants 2 participants 2 participants
3.427  (0.6978) 6.017  (5.3303) 5.355  (0.4256)
Small bowel (RT: Muscle) Number Analyzed 2 participants 2 participants 2 participants
15.353  (7.1430) 12.585  (6.1981) 11.352  (2.5753)
[1]
Standard deviation cannot be calculated when only one participant analyzed.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 0)
Comments Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 21)
Comments Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 0)
Comments Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.426
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 21)
Comments Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.098
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 0)
Comments Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.813
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 21)
Comments Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.813
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 0)
Comments Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.297
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection ITT Population (Pre-dose), ITT Population (Day 21)
Comments Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.469
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
10.Secondary Outcome
Title The 3D-SUV-R of Malignant Lesions for Session 2
Hide Description The tumor contrast, i.e. the SUV ratio for 3D-SUV-R of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RTs. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.
Time Frame At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
Arm/Group Title ITT Population (Day 0) ITT Population (Day 21)
Hide Arm/Group Description:
Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.
Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: ratio
Bone (RT: Bone): At 0.5 hour Number Analyzed 2 participants 0 participants
11.191  (8.6266)
Bone (RT: Bone): At 1 hour Number Analyzed 2 participants 2 participants
9.679  (9.2426) 5.891  (0.7682)
Bone (RT: Bone): At 2 hour Number Analyzed 2 participants 0 participants
6.243  (1.3313)
Bone (RT: Bone): At 4 hour Number Analyzed 2 participants 0 participants
2.169  (0.2056)
Bone (RT: Muscle): At 0.5 hour Number Analyzed 2 participants 0 participants
6.716  (1.4013)
Bone (RT: Muscle): At 1 hour Number Analyzed 2 participants 2 participants
5.528  (2.1555) 5.530  (0.8944)
Bone (RT: Muscle): At 2 hour Number Analyzed 2 participants 0 participants
5.311  (2.1658)
Bone (RT: Muscle): At 4 hour Number Analyzed 2 participants 0 participants
2.331  (0.5535)
Liver (RT: Liver): At 0.5 hour Number Analyzed 9 participants 0 participants
2.547  (1.5468)
Liver (RT: Liver): At 1 hour Number Analyzed 9 participants 9 participants
3.071  (2.3858) 2.514  (0.6087)
Liver (RT: Liver): At 2 hour Number Analyzed 9 participants 0 participants
2.430  (0.9559)
Liver (RT: Liver): At 4 hour Number Analyzed 9 participants 0 participants
2.038  (0.6822)
Liver (RT: Muscle): At 0.5 hour Number Analyzed 9 participants 0 participants
11.534  (8.0671)
Liver (RT: Muscle): At 1 hour Number Analyzed 9 participants 9 participants
13.231  (10.4892) 9.653  (5.1879)
Liver (RT: Muscle): At 2 hour Number Analyzed 9 participants 0 participants
9.383  (6.1356)
Liver (RT: Muscle): At 4 hour Number Analyzed 9 participants 0 participants
6.974  (6.4729)
Lymph node (RT: Lymph node): At 0.5 hour Number Analyzed 7 participants 0 participants
13.448  (12.3973)
Lymph node (RT: Lymph node): At 1 hour Number Analyzed 7 participants 7 participants
10.109  (7.3722) 14.166  (13.4067)
Lymph node (RT: Lymph node): At 2 hour Number Analyzed 7 participants 0 participants
9.722  (7.1821)
Lymph node (RT: Lymph node): At 4 hour Number Analyzed 7 participants 0 participants
9.889  (5.8842)
Lymph node (RT: Muscle): At 0.5 hour Number Analyzed 7 participants 0 participants
16.362  (9.1362)
Lymph node (RT: Muscle): At 1 hour Number Analyzed 7 participants 7 participants
20.434  (13.6060) 18.562  (15.1302)
Lymph node (RT: Muscle): At 2 hour Number Analyzed 7 participants 0 participants
16.107  (9.5271)
Lymph node (RT: Muscle): At 4 hour Number Analyzed 7 participants 0 participants
8.619  (3.7444)
Peritoneum (RT: Peritoneum): At 0.5 hour Number Analyzed 1 participants 0 participants
1.767 [1]   (NA)
Peritoneum (RT: Peritoneum): At 1 hour Number Analyzed 1 participants 1 participants
6.494 [1]   (NA) 8.173 [1]   (NA)
Peritoneum (RT: Peritoneum): At 2 hour Number Analyzed 1 participants 0 participants
8.747 [1]   (NA)
Peritoneum (RT: Peritoneum): At 4 hour Number Analyzed 1 participants 0 participants
4.809 [1]   (NA)
Peritoneum (RT: Muscle): At 0.5 hour Number Analyzed 1 participants 0 participants
4.431 [1]   (NA)
Peritoneum (RT: Muscle): At 1 hour Number Analyzed 1 participants 1 participants
8.508 [1]   (NA) 10.060 [1]   (NA)
Peritoneum (RT: Muscle): At 2 hour Number Analyzed 1 participants 0 participants
7.709 [1]   (NA)
Peritoneum (RT: Muscle): At 4 hour Number Analyzed 1 participants 0 participants
2.626 [1]   (NA)
Small bowel (RT: Small bowel): At 0.5 hour Number Analyzed 3 participants 0 participants
3.759  (2.1690)
Small bowel (RT: Small bowel): At 1 hour Number Analyzed 3 participants 3 participants
5.644  (4.9619) 4.956  (2.8311)
Small bowel (RT: Small bowel): At 2 hour Number Analyzed 3 participants 0 participants
4.363  (2.5614)
Small bowel (RT: Small bowel): At 4 hour Number Analyzed 2 participants 0 participants
4.047  (1.6457)
Small bowel (RT: Muscle): At 0.5 hour Number Analyzed 3 participants 0 participants
9.404  (5.2820)
Small bowel (RT: Muscle): At 1 hour Number Analyzed 3 participants 3 participants
11.787  (5.8090) 7.678  (3.9023)
Small bowel (RT: Muscle): At 2 hour Number Analyzed 3 participants 0 participants
7.267  (3.8995)
Small bowel (RT: Muscle): At 4 hour Number Analyzed 2 participants 0 participants
6.686  (1.5046)
[1]
Standard deviation cannot be calculated when only one participant analyzed.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ITT Population (Day 0), ITT Population (Day 21)
Comments Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.910
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ITT Population (Day 0), ITT Population (Day 21)
Comments Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ITT Population (Day 0), ITT Population (Day 21)
Comments Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.375
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ITT Population (Day 0), ITT Population (Day 21)
Comments Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.219
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
11.Secondary Outcome
Title Percent Change in 3D-SUV-R of Malignant Lesions
Hide Description The tumor contrast, i.e. the SUV ratio for 3D-SUV-R of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RT. For percent change, 68Ga-OPS202 receptor scan is compared to previous somatostatin receptor scan.
Time Frame 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
Arm/Group Title ITT Population (Day 0) ITT Population (Day 21)
Hide Arm/Group Description:
Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.
Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: percent change
Bone (RT: Bone) Number Analyzed 2 participants 2 participants
-13.315  (65.0759) -0.418  (32.2352)
Bone (RT: Muscle) Number Analyzed 2 participants 2 participants
16.042  (3.0132) 20.052  (47.7825)
Liver (RT: Liver) Number Analyzed 9 participants 9 participants
51.938  (33.2221) 50.766  (25.4179)
Liver (RT: Muscle) Number Analyzed 9 participants 9 participants
-5.165  (32.3975) -19.838  (37.5669)
Lymph node (RT: Lymph node) Number Analyzed 7 participants 7 participants
56.044  (94.8768) 38.530  (117.3139)
Lymph node (RT: Muscle) Number Analyzed 7 participants 7 participants
46.569  (61.4515) 36.864  (79.3287)
Peritoneum (RT: Peritoneum) Number Analyzed 1 participants 1 participants
-14.239 [1]   (NA) -19.962 [1]   (NA)
Peritoneum (RT: Muscle) Number Analyzed 1 participants 1 participants
9.619 [1]   (NA) 36.256 [1]   (NA)
Small bowel (RT: Small bowel) Number Analyzed 2 participants 2 participants
63.131  (122.3379) 58.296  (19.8143)
Small bowel (RT: Muscle) Number Analyzed 2 participants 2 participants
2.447  (88.0324) -12.716  (57.3817)
[1]
Standard deviation cannot be calculated when only one participant analyzed.
12.Secondary Outcome
Title Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location
Hide Description For determining a suitable time window for PET/CT with 68Ga-OPS202, the scans after administration of the 15 μg peptide dose were analyzed and the time point with the highest lesion number per tissue location and overall were determined. If the highest number of lesion was detected at more than one time point, the earliest time point was used.
Time Frame At 0.5, 1, 2, and 4 hour post-injection on Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
Arm/Group Title ITT Population (Day 0)
Hide Arm/Group Description:
Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
Total Number Analyzed 12 participants
At 0.5 hour 5
At 1 hour 3
At 2 hour 4
At 4 hour 0
Bone Number Analyzed 2 participants
At 0.5 hour 2
At 1 hour 0
At 2 hour 0
At 4 hour 0
Liver Number Analyzed 9 participants
At 0.5 hour 2
At 1 hour 3
At 2 hour 4
At 4 hour 0
Lung Number Analyzed 0 participants
At 0.5 hour
At 1 hour
At 2 hour
At 4 hour
Lymph node Number Analyzed 7 participants
At 0.5 hour 7
At 1 hour 0
At 2 hour 0
At 4 hour 0
Mamma Number Analyzed 0 participants
At 0.5 hour
At 1 hour
At 2 hour
At 4 hour
Pancreas Number Analyzed 1 participants
At 0.5 hour 1
At 1 hour 0
At 2 hour 0
At 4 hour 0
Peritoneum Number Analyzed 1 participants
At 0.5 hour 1
At 1 hour 0
At 2 hour 0
At 4 hour 0
Small bowel Number Analyzed 3 participants
At 0.5 hour 3
At 1 hour 0
At 2 hour 0
At 4 hour 0
Thyroid gland Number Analyzed 0 participants
At 0.5 hour
At 1 hour
At 2 hour
At 4 hour
13.Secondary Outcome
Title Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value
Hide Description The time point with the highest mean 3D-SUV-R per tissue location were determined. If the highest mean 3D-SUV-R was detected at more than one time point, the earliest time point was used.
Time Frame At 0.5, 1, 2, and 4 hour post-injection on Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
Arm/Group Title ITT Population (Day 0)
Hide Arm/Group Description:
Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.
Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
Bone (RT: Bone) Number Analyzed 2 participants
At 0.5 hour 1
At 1 hour 0
At 2 hour 1
At 4 hour 0
Bone (RT: Muscle) Number Analyzed 2 participants
At 0.5 hour 1
At 1 hour 0
At 2 hour 1
At 4 hour 0
Liver (RT: Liver) Number Analyzed 9 participants
At 0.5 hour 0
At 1 hour 4
At 2 hour 2
At 4 hour 3
Liver (RT: Muscle) Number Analyzed 9 participants
At 0.5 hour 2
At 1 hour 5
At 2 hour 2
At 4 hour 0
Lymph node (RT: Lymph node) Number Analyzed 7 participants
At 0.5 hour 2
At 1 hour 1
At 2 hour 2
At 4 hour 2
Lymph node (RT: Muscle) Number Analyzed 7 participants
At 0.5 hour 1
At 1 hour 5
At 2 hour 1
At 4 hour 0
Mamma (RT: Mamma) Number Analyzed 0 participants
At 0.5 hour
At 1 hour
At 2 hour
At 4 hour
Mamma (RT: Muscle) Number Analyzed 0 participants
At 0.5 hour
At 1 hour
At 2 hour
At 4 hour
Peritoneum (RT: Peritoneum) Number Analyzed 1 participants
At 0.5 hour 0
At 1 hour 0
At 2 hour 1
At 4 hour 0
Peritoneum (RT: Muscle) Number Analyzed 1 participants
At 0.5 hour 0
At 1 hour 1
At 2 hour 0
At 4 hour 0
Small bowel (RT: Small bowel) Number Analyzed 3 participants
At 0.5 hour 1
At 1 hour 2
At 2 hour 0
At 4 hour 0
Small bowel (RT: Muscle) Number Analyzed 3 participants
At 0.5 hour 0
At 1 hour 3
At 2 hour 0
At 4 hour 0
14.Secondary Outcome
Title Best Diagnostic Scan Assessment
Hide Description The assessment of every diagnostic 68Ga-OPS202 PET/CT scan of session 2 was rated by the reader from 1 to 5, where 1=worst diagnostic scan and 5=best diagnostic scan. Higher score indicates a better scan.
Time Frame At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.
Arm/Group Title ITT Population (Day 0) ITT Population (Day 21)
Hide Arm/Group Description:
Participants received a single intravenous dose of 15 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 0 prior to PET/CT scan.
Participants received a single intravenous dose of 50 (± 5) μg of OPS202 peptide plus 68Ga at a fixed dose of 200 MBq (± 25%) per injection on Day 21 prior to PET/CT scan.
Overall Number of Participants Analyzed 12 12
Median (Full Range)
Unit of Measure: score on a scale
At 0.5 hour Number Analyzed 12 participants 0 participants
4.0
(2 to 5)
At 1 hour Number Analyzed 12 participants 12 participants
5.0
(3 to 5)
5.0
(3 to 5)
At 2 hour Number Analyzed 12 participants 0 participants
4.5
(3 to 5)
At 4 hour Number Analyzed 12 participants 0 participants
2.0
(1 to 4)
Time Frame From start of IP administration to end of the study visit (approximately 28 to 36 days).
Adverse Event Reporting Description The SAF included all participants of the FAS who received the IP, regardless of any protocol deviations.
 
Arm/Group Title All Participants
Hide Arm/Group Description Participants received a single dose of the OPS202 peptide (15 [± 5] μg on Day 0. All doses were labeled with 68Ga at a fixed dose of 200 MBq (± 25%) per injection. 68Ga-OPS202 was administered intravenously over a time period of less than 1 minute prior to 3D PET/CT scan. As per the sequential dosing scheme, on Day 21, participants then received a single dose of 50 (± 15) μg of 68Ga-OPS202 prior to 3D PET/CT.
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   0/12 (0.00%)    
Hide Serious Adverse Events
All Participants
Affected / at Risk (%) # Events
Total   0/12 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%) # Events
Total   6/12 (50.00%)    
Blood and lymphatic system disorders   
Eosinophilia  1  1/12 (8.33%)  1
Gastrointestinal disorders   
Abdominal pain upper  1  1/12 (8.33%)  1
Diarrhoea  1  1/12 (8.33%)  1
General disorders   
Fatigue  1  2/12 (16.67%)  2
Infections and infestations   
Urinary tract infection  1  2/12 (16.67%)  2
Nasopharyngitis  1  1/12 (8.33%)  1
Investigations   
Liver function test abnormal  1  1/12 (8.33%)  1
Nervous system disorders   
Headache  1  1/12 (8.33%)  1
Skin and subcutaneous tissue disorders   
Rash  1  1/12 (8.33%)  1
1
Term from vocabulary, MedDRA 17.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Ipsen
Phone: see email
EMail: clinical.trials@ipsen.com
Layout table for additonal information
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02162446    
Other Study ID Numbers: OPS-B-001
2014-001881-88 ( EudraCT Number )
First Submitted: June 3, 2014
First Posted: June 12, 2014
Results First Submitted: July 5, 2019
Results First Posted: October 2, 2019
Last Update Posted: October 2, 2019