Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
800 participants
OBSERVATIONAL
2018-07-11
2028-09-30
Brief Summary
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This study proposes 68Gallium(68Ga)-DOTATOC positron emission tomography/computed tomography (PET/CT) is superior to current imaging techniques. The goal is to evaluate the safety and sensitivity of 68Ga-DOTATOC PET/CT at detecting NETs and other tumors with over-expression of somatostatin receptors.
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Detailed Description
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After providing informed written consent subjects will complete a medical history questionnaire.
Monitoring of adverse events There will be short-term evaluation of adverse events by comparison of vital signs before and after administration of 68Ga-DOTATOC. Twenty-four hours after 68Ga-DOTATOC administration the study coordinator will call the patient and see if they have experienced any adverse events during that time period and complete the adverse event questionnaire found in section 9.6.
Follow-up Assessments
The following information will be collected up to 3 years following the PET/CT scans:
* Initiation of a new treatment
* Laboratory results and pathology reports
* Results of imaging studies
* Final clinical diagnosis by physician and relevant clinical notes
The study is expected to take approximately 4 years for accrual.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PET/CT Diagnostic Imaging
Each subject will have two PET/CT scans, one using 68Ga-DOTATOC and the other using 18F-FDG. The 68Ga-DOTATOC radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. 18F-FDG is considered standard care and has been approved by Health Canada.
68Ga-DOTATOC PET/CT
Blood pressure, heart rate, and oxygen saturation levels will be recorded prior to the injection and at 5 - 15 minutes after injection.
Each study subject will have an intravenous catheter inserted. The subject will receive a bolus intravenous dose of the radiotracer from an approved study supplier site.
The subject will rest in a comfortable chair for 60 minutes. After this uptake phase, the blood pressure, heart rate, and oxygen saturation levels will be recorded again. The subjects will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract.
Subjects are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired.
18F-FDG PET/CT
18F-FDG PET/CT For 18F-FDG as fasting period of 6 hours is required before the scan.
Each study subject will have an intravenous catheter inserted. The subject will receive a bolus intravenous dose of the radiotracer from an approved study supplier site.
The subject will rest in a comfortable chair for 60 minutes. The subjects will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract.
Subjects are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired.
Interventions
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68Ga-DOTATOC PET/CT
Blood pressure, heart rate, and oxygen saturation levels will be recorded prior to the injection and at 5 - 15 minutes after injection.
Each study subject will have an intravenous catheter inserted. The subject will receive a bolus intravenous dose of the radiotracer from an approved study supplier site.
The subject will rest in a comfortable chair for 60 minutes. After this uptake phase, the blood pressure, heart rate, and oxygen saturation levels will be recorded again. The subjects will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract.
Subjects are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired.
18F-FDG PET/CT
18F-FDG PET/CT For 18F-FDG as fasting period of 6 hours is required before the scan.
Each study subject will have an intravenous catheter inserted. The subject will receive a bolus intravenous dose of the radiotracer from an approved study supplier site.
The subject will rest in a comfortable chair for 60 minutes. The subjects will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract.
Subjects are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired.
Eligibility Criteria
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Inclusion Criteria
* World health organization performance status 0-2
* Able to provide written informed consent/assent (or consent by guardian for subjects \<19 years)
* Patients must be able to tolerate the physical/logistical requirements of completing a PET scan including lying flat for up to 30 minutes and tolerating intravenous cannulation for injection.
Patients must require imaging for either staging or re-staging of:
* Gastroenteropancreatic tumors (e.g. carcinoids, gastrinoma, insulinoma, glucagonoma, VIPoma, etc.), functioning and non-functioning
* Sympathoadrenal system tumors (phaeochromocytoma, paraganglioma, neuroblastoma, ganglioneuroma)
* Medullary thyroid carcinoma
* Pituitary adenoma
* Medulloblastoma
* Merkel cell carcinoma
* Small-cell lung cancer (mainly primary tumors)
* Meningioma
* Or any other NET / with potential for overexpression of SSTR
Exclusion Criteria
* Patients who are medically unstable ex: acute cardiac or respiratory distress, hypotensive
* Patients who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT bore (diameter 70cm).
18 Years
100 Years
ALL
No
Sponsors
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British Columbia Cancer Agency
OTHER
Responsible Party
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Principal Investigators
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Francois Benard, MD
Role: PRINCIPAL_INVESTIGATOR
BC Cancer
Locations
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BC Cancer
Vancouver, British Columbia, Canada
Countries
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Other Identifiers
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H17-00909
Identifier Type: -
Identifier Source: org_study_id
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