DOTATOC PET/CT for Imaging NET Patients
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- STATUS
- Recruiting
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- End date
- Dec 31, 2026
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- participants needed
- 400
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- sponsor
- British Columbia Cancer Agency
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.
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.
Details
| Condition | Neuroendocrine Tumors, Insulinoma, Gastrinoma, Glucagonoma, Vipoma, Pheochromocytoma, Paraganglioma, Neuroblastoma, Ganglioneuroma, Medullary Carcinoma, Pituitary Adenoma, Medulloblastoma, Merkel Cell Carcinoma, Small-cell Lung Cancer, Meningioma, Carcinoid |
|---|---|
| Treatment | 68Ga-DOTATOC PET/CT, 18F-FDG PET/CT |
| Clinical Study Identifier | NCT03583528 |
| Sponsor | British Columbia Cancer Agency |
| Last Modified on | 24 March 2022 |
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