DOTATOC PET/CT for Imaging NET Patients

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Adenoma
Carcinoid
Carcinoma
Carcinoma, Merkel Cell
Ganglioneuroma
Gastrinoma
Glucagonoma
Insulinoma
Medullary Carcinoma
Medulloblastoma
Meningioma
Merkel Cell Carcinoma
Neuroblastoma
Neuroendocrine Tumors
Paraganglioma
Pheochromocytoma
Pituitary Adenoma
Pituitary Neoplasms
Small Cell Lung Carcinoma
Small-cell Lung Cancer
Vipoma

Clinical Trial Details

NCT number	NCT03583528
Study type	Observational
Source	British Columbia Cancer Agency
Contact	Heather Saprunoff
Phone	604-877-6000
Email	hsaprunoff@bccancer.bc.ca
Status	Recruiting
Phase
Start date	July 11, 2018
Completion date	December 31, 2028

View Details

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