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Trial record 11 of 47 for:    DOTATATE | Neuroendocrine Tumors

Evaluation of 68Gallium-DOTATATE PET/CT for Detecting Neuroendocrine Tumors

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ClinicalTrials.gov Identifier: NCT01967537
Recruitment Status : Active, not recruiting
First Posted : October 23, 2013
Results First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Naris Nilubol, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Neuroendocrine Tumors
Von Hippel-Lindau Syndrome
Hippel-Lindau Disease
Interventions Drug: 68Gallium DOTATATE
Procedure: Radio-guided surgery
Enrollment 341
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 68Gallium DOTATATE Imaging
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68Gallium DOTATATE imaging

68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.

Radio-guided surgery: Using 68Gallium DOTATATE

Period Title: Overall Study
Started 341
Completed 281
Not Completed 60
Reason Not Completed
Withdrawal by Subject             52
Refuse treatment             2
Lost to Follow-up             6
Arm/Group Title 68Gallium DOTATATE Imaging
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68Gallium DOTATATE imaging

68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.

Radio-guided surgery: Using 68Gallium DOTATATE

Overall Number of Baseline Participants 341
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 341 participants
<=18 years
1
   0.3%
Between 18 and 65 years
238
  69.8%
>=65 years
102
  29.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 341 participants
55.89  (14.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 341 participants
Female
194
  56.9%
Male
147
  43.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 341 participants
American Indian or Alaska Native
1
   0.3%
Asian
9
   2.6%
Black or African American
24
   7.0%
Native Hawaiian or Other Pacific Islander
1
   0.3%
Other
7
   2.1%
Race Unknown
9
   2.6%
White
290
  85.0%
Hispanic or Latino
17
   5.0%
Not Hispanic or Latino
323
  94.7%
Ethnicity Unknown
1
   0.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 341 participants
341
 100.0%
1.Primary Outcome
Title Number of Lesions Detected Using the 68Gallium-DOTATATE Positron Emission Tomography (PET/Computed Tomography (CT)) Scan
Hide Description Patients with neuroendocrine tumors (NETs) were scanned with the 68Gallium-DOTATATE Positron Emission Tomography (PET/Computed Tomography (CT)) and the number of lesions detected are collected.
Time Frame During PET Scan, up to 2 hours annually for up to 5 years
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Hide Analysis Population Description
Analysis was performed in the initial 131/341 participants scanned because 52 withdrew consent and 2 refused treatment. Subsequent scans in the remaining 156 participants were used to assess secondary objectives.
Arm/Group Title 68Gallium DOTATATE Imaging
Hide Arm/Group Description:

68Gallium DOTATATE imaging

68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.

Radio-guided surgery: Using 68Gallium DOTATATE

Overall Number of Participants Analyzed 131
Measure Type: Number
Unit of Measure: Number of lesions
847
2.Secondary Outcome
Title Mean Radiation Activity Between Low Grade and Intermediate Grade Neuroendocrine Tumor
Hide Description The radioactivity was assessed using intraoperative radiation detector following the 68Gallium-DOTATATE injection. Low grade neuroendocrine tumors is defined as tumors with slow cell division determined in histology. Low grade tumors is associated with the best outcome. Intermediate grade tumor is defined as the tumor with medium (3-20%) rate of actively dividing cells and is associated with less favorably outcome.
Time Frame During radioguided surgery, up to 2 hours
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Hide Analysis Population Description
As of 12/22/14 when the analysis was performed, 14/140 subjects required surgical intervention with intraoperative radiation detector and thus were analyzed. 126 participants were not surgical candidates or did not receive intraoperative dose of 68Gallium-DOTATATE and did not have radiation detector.
Arm/Group Title 68Gallium DOTATATE Imaging
Hide Arm/Group Description:

68Gallium DOTATATE imaging

68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.

Radio-guided surgery: Using 68Gallium DOTATATE

Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: 511KeV count per ten seconds
Low grade 504.9  (534)
Intermediate grade 205  (147)
3.Secondary Outcome
Title Tumor Volume of Neuroendocrine Tumors Assessed by the 68Gallium-DOTATATE Scan
Hide Description Participants were scanned using the 68Gallium-DOTATATE Scan. Tumor volume more than 7ml is associated with shorter time to disease progression. Tumor volume more than 36 ml is associated with shorter disease specific survival.
Time Frame During radioguided surgery, up to 2 hours
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Hide Analysis Population Description
184/341 participants were analyzed because 52 withdrew consent and 2 refused treatment, 22 did not have a diagnosis of neuroendocrine tumor, and 81 had no 68Ga-DOTATATE uptake and were excluded.
Arm/Group Title 68Gallium DOTATATE Imaging
Hide Arm/Group Description:

68Gallium DOTATATE imaging

68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.

Radio-guided surgery: Using 68Gallium DOTATATE

Overall Number of Participants Analyzed 184
Median (Full Range)
Unit of Measure: ml
9.24
(0.06 to 1136.7)
4.Secondary Outcome
Title Median Radioactivity of Tumors With High Expression of Somatostatin Receptor 2 Compared to Tumors With Intermediate Expression of Somatostatin Receptor 2
Hide Description High expression of somatostatin receptor 2 (SSTR2) is based on the intensity grading on immunohistochemistry. High SSTR2 expression may be associated with well-differentiated tumor and high avidity on DOTATATE scan, compared to intermediate or low expression of SSTR that can be seen in poorly differentiated and often aggressive neuroendocrine tumors. Because the correlation can only be from the comparison of preoperative DOTATATE and the tumors that were removed, it is a one time analysis. Subsequent DOTATATE studies are for surveillance and follow up for disease progression or recurrence.
Time Frame During PET Scan, up to 2 hours annually
Hide Outcome Measure Data
Hide Analysis Population Description
As of 12/22/14 when the analysis was performed, 12/140 subj. required surgical intervention with intraoperative radiation detector & thus were analyzed. 12 subj. had their tumors analyzed for the expression of SSTR, 126 subj. were not surgical candidates or did not receive intraoperative dose of 68Gallium-DOTATATE & did not have radiation detector.
Arm/Group Title 68Gallium DOTATATE Imaging
Hide Arm/Group Description:

68Gallium DOTATATE imaging

68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.

Radio-guided surgery: Using 68Gallium DOTATATE

Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: Tumor to background ratio
High expression
6.5
(3.4 to 14.9)
Low expression
3.7
(3.5 to 6.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 68Gallium DOTATATE Imaging
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Mann-Whitney
Comments [Not Specified]
5.Secondary Outcome
Title The Number of Tumors Identified in Participants by the Radiation Detector During Radio-guided Surgery Using 68Gallium-DOTATATE
Hide Description Radio-guided surgery in neuroendocrine tumors using 68Gallium-DOTATATE was performed to detect tumors in the stomach and small bowel neuroendocrine tumors, pancreas, metastatic sites to lymph nodes and liver, and pheochromocytoma or paraganglioma. The number of tumors identified by the radiation detector were assessed.
Time Frame Radio-guided surgery, up to 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
As of 02.14.2018 when the analysis was performed, 44/326 subjects required surgical intervention with intraoperative radiation detector and thus were analyzed for the number of tumors identified. 282 participants were not surgical candidates and did not receive intraoperative dose of 68 Gallium-DOTATATE and did not have radiation detector used.
Arm/Group Title 68Gallium DOTATATE Imaging
Hide Arm/Group Description:

68Gallium DOTATATE imaging

68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.

Radio-guided surgery: Using 68Gallium DOTATATE

Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: Number of tumors
Stomach and small bowel 23
Pancreas tumors 24
Pheochromocytoma and paraganglioma 6
Liver metastasis 9
Metastatic lymph nodes 71
6.Secondary Outcome
Title Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Date treatment consent signed to date off study, approximately 50 months and 17 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 68Gallium DOTATATE Imaging
Hide Arm/Group Description:

68Gallium DOTATATE imaging

68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.

Radio-guided surgery: Using 68Gallium DOTATATE

Overall Number of Participants Analyzed 341
Measure Type: Count of Participants
Unit of Measure: Participants
21
   6.2%
Time Frame Date treatment consent signed to date off study, approximately 50 months and 17 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 68Gallium DOTATATE Imaging
Hide Arm/Group Description

68Gallium DOTATATE imaging

68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.

Radio-guided surgery: Using 68Gallium DOTATATE

All-Cause Mortality
68Gallium DOTATATE Imaging
Affected / at Risk (%)
Total   16/341 (4.69%)    
Show Serious Adverse Events Hide Serious Adverse Events
68Gallium DOTATATE Imaging
Affected / at Risk (%) # Events
Total   20/341 (5.87%)    
General disorders   
Death (unrelated to 68 Gallium DOTATATE)  1  16/341 (4.69%)  16
Metabolism and nutrition disorders   
Hyperglycemia  1  1/341 (0.29%)  1
Vascular disorders   
Thromboembolic event  1  3/341 (0.88%)  3
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
68Gallium DOTATATE Imaging
Affected / at Risk (%) # Events
Total   1/341 (0.29%)    
Nervous system disorders   
Alteration of consciousness  1  1/341 (0.29%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: Dr. Naris Nilubol
Organization: Principal Investigator
Phone: 301-451-2355
Responsible Party: Naris Nilubol, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01967537     History of Changes
Other Study ID Numbers: 130193
13-C-0193
First Submitted: October 18, 2013
First Posted: October 23, 2013
Results First Submitted: November 19, 2018
Results First Posted: April 2, 2019
Last Update Posted: April 2, 2019