Neuroendocrine Tumor Clinical Trials

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Pragmatic Study on the Use of 68Ga-DOTA-TATE PET|CT Imaging as a Standard of Care to Influence Clinical Management

Who is this study for? Patients with neuroendocrine cancer
What treatments are being studied? 68Ga-DOTA-TATE
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This clinical trial is a pragmatic study aiming to evaluate the innocuity/safety profile of the PET radiotracer 68Ga-DOTA-TATE, and to establish the procedure as a routine standard-of-care diagnostic tool for all neuro-endocrine cancer patients. It is a single-center study, but with recruitment across all Canada. The trial is prospective, non-randomized, open-label and with no control group. The superiority of this procedure over the former standard-of-care (Octreoscan) was already established in previous and numerous studies across the world. As such, the current trial aims to gather data to further support the implementation of 68Ga-DOTA-TATE as the new standard-of-care for neuro-endocrine tumors (NET).

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Clinical requisition for a 68Ga-DOTA-TATE PET/CT signed by a referring doctor

• Patients with suspected or proven tumors expressing somatostatin receptors

• Informed consent by patient (or parents if patient is less than 18 years of age)

Locations
Other Locations
Canada
Centre Intégré Universitaire de Santé et des Services Sociaux du Centre de l'Ouest de Montréal - Jewish General Hospital
RECRUITING
Montreal
CHUS
RECRUITING
Sherbrooke
Contact Information
Primary
Stéphanie Dubreuil
Stephanie.Dubreuil2@usherbrooke.ca
819-346-1110
Time Frame
Start Date: 2020-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 5000
Treatments
Experimental: Neuroendocrine cancer patients
All neuroendocrine cancer patients referred by their physician and fulfilling the eligibility criteria across Canada can be recruited to the primary site of the study. Patients will be injected intravenously with 3 MBq/kg (maximum 370 MBq) of 68Ga-DOTA-TATE. 45-90 minutes following injection, patients will be imaged in a PET/CT scanner. Images will be analyzed by a trained nuclear medicine physician.~Safety profile, eventual adverse effects, false positives, false negatives and any abnormal biodistribution of the radiotracer will be monitored and analysed.
Related Therapeutic Areas
Sponsors
Leads: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborators: Université de Sherbrooke, Jewish General Hospital

This content was sourced from clinicaltrials.gov