Brief Title
DOTATOC PET/CT for Imaging NET Patients
Official Title
Evaluation of the Safety and Sensitivity of 68Ga-DOTATOC PET/CT for Imaging NET Patients
Brief Summary
Neuroendocrine tumours (NETs) are generally slow growing, but some can be aggressive and resistant to treatment. Compared to healthy cells, the surface of these tumor cells has a greater number of special molecules called somatostatin receptors (SSTR). Somatostatin receptor scintigraphy and conventional imaging are used to detect NETs. 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.
Detailed Description
Each subject will have two PET/CT scans, one using 68Ga-DOTATOC and the other using 18-Fluoride-Fluorodeoxyglucose (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. 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.
Study Type
Observational
Primary Outcome
Sensitivity of 68Ga-DOTATOC PET/CT in the diagnosis of SSTR positive tumors.
Secondary Outcome
Number of participants with 68Ga-DOTATOC-related adverse events as assessed by abnormal vital sign measurement.
Condition
Neuroendocrine Tumors
Intervention
68Ga-DOTATOC PET/CT
Study Arms / Comparison Groups
PET/CT Diagnostic Imaging
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
400
Start Date
July 11, 2018
Completion Date
December 31, 2026
Primary Completion Date
December 31, 2023
Eligibility Criteria
Inclusion Criteria: All subjects: - 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: - Pregnancy - 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).
Gender
All
Ages
18 Years - 100 Years
Accepts Healthy Volunteers
No
Contacts
Francois Benard, MD, 604-877-6000, [email protected]
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT03583528
Organization ID
H17-00909
Responsible Party
Sponsor
Study Sponsor
British Columbia Cancer Agency
Study Sponsor
Francois Benard, MD, Principal Investigator, BC Cancer
Verification Date
February 2022