Trials / Active Not Recruiting

Active Not RecruitingNCT03583528

DOTATOC PET/CT for Imaging NET Patients

Evaluation of the Safety and Sensitivity of 68Ga-DOTATOC PET/CT for Imaging NET Patients

Status: Active Not Recruiting
Phase: —
Study type: Observational
Enrollment: 800 (estimated)

Sponsor: British Columbia Cancer Agency · Academic / Other
Sex: All
Age: 18 Years – 100 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.

Timeline

Start date: 2018-07-11
Primary completion: 2025-09-30
Completion: 2028-09-30
First posted: 2018-07-11
Last updated: 2025-06-13

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT03583528. Inclusion in this directory is not an endorsement.