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Trial record 63 of 2732 for:    Neoplasms | Neuroendocrine Tumors

Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan

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ClinicalTrials.gov Identifier: NCT03136328
Recruitment Status : Completed
First Posted : May 2, 2017
Results First Posted : January 30, 2019
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
NCM USA
Information provided by (Responsible Party):
Charito Love, Montefiore Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Neuroendocrine Tumors
Intervention Drug: 68Ga-DOTATOC
Enrollment 11
Recruitment Details Participants were recruited at Montefiore Medical Center which has medical specializing in the diagnosis and treatment of NETs. Eligible participants were those referred by their physicians for PET (Positron Emission Tomography) or CT imaging due to suspected or confirmed NETs.
Pre-assignment Details  
Arm/Group Title 68Ga-DOTATOC PET/CT
Hide Arm/Group Description Study participants will receive Gallium 68 (68Ga)-DOTATOC and undergo a PET/CT imaging study.
Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title 68Ga-DOTATOC PET/CT
Hide Arm/Group Description Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study to measure its ability to detect primary NET and any metastasis.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
68Ga-DOTATOC PET/CT will be compared with final diagnoses for sensitivity, specificity and accuracy for detecting NET primary lesion and/or metastases. Results will be compared with conventional imaging results.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
55.3  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
9
  81.8%
Male
2
  18.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
 100.0%
1.Primary Outcome
Title Sensitivity to Correctly Diagnose NET
Hide Description Sensitivity to detect NET will be assessed and compared with conventional imaging modality. Sensitivity is the ability of an agent to indicate the presence and location of NET. The ability of 68Ga-DOTATOC to localize more effectively to somatostatin receptors and the exquisite spatial resolution of PET/CT should make easier detection of primary and metastatic neuroendocrine tumors and allow better measurement of tumor burden. Sensitivity is the percentage of accurately diagnosed NET cases. All participants underwent conventional imaging with either Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) as standard care prior to 68Ga-DOTATOC imaging.
Time Frame During imaging process ( approximately 120 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 68Ga-DOTATOC PET/CT Conventional Imaging
Hide Arm/Group Description:
Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study.
All participants underwent conventional imaging with either Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) or In-111 Octreoscan as standard care prior to 68Ga-DOTATOC imaging.
Overall Number of Participants Analyzed 11 11
Measure Type: Number
Unit of Measure: percent of NET correctly diagnosed
Primary lesions 75 75
Liver metastases 100 75
Lymph node metastasis 100 40
Bone metastasis 100 50
2.Secondary Outcome
Title Specificity to Detect True Negative
Hide Description A tumor is an abnormal growth of cells which can be malignant or not. NET tumors secrete hormones that will disrupt the normal ecology of the body. 68Ga-DOTATOC is extremely sensitive and specific to the receptors expressed by NET. These attributes are unique to 68Ga-DOTATOC and makes it the only imagining technique that can determine whether or not lesions detected by conventional imaging is due to NET involvement. 68Ga-DOTATOC is able to exclude disease involvement in lesions detected on CT/MRI; this ability to exclude disease involvement is called Specificity. The reported values indicate the specificity of 68Ga-DOTATOC, which is the percentage of tumors detected by conventional imagining that 68Ga-DOTATOC correctly determined were not due to NET involvement (i.e. identifying true negative for NET).
Time Frame During imaging process ( approximately 120 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 68Ga-DOTATOC PET/CT
Hide Arm/Group Description:
Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: percent of tumors identified as non-NET
Primary lesions 100
Liver metastases 100
Time Frame The somatostatin analogue being administered is a short acting agent that, if it caused an adverse effect, would be seen within a few minutes after administration. Participants were monitored for one hour after injection. Participants were systematically assessed and questioned regarding changes in sensation or appearance of new symptom.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 68Ga-DOTATOC PET/CT
Hide Arm/Group Description Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study.
All-Cause Mortality
68Ga-DOTATOC PET/CT
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
68Ga-DOTATOC PET/CT
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
68Ga-DOTATOC PET/CT
Affected / at Risk (%)
Total   0/11 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Charito Love, MD
Organization: Montefiore Medical Center
Phone: 718-406-8462
Responsible Party: Charito Love, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03136328     History of Changes
Other Study ID Numbers: 15-06-274
First Submitted: April 5, 2017
First Posted: May 2, 2017
Results First Submitted: November 28, 2018
Results First Posted: January 30, 2019
Last Update Posted: March 7, 2019