NCT04847505

68Ga-DOTA-TATE PET/CT Imaging in NETs

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,000 (estimated)
• Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	68Ga-DOTA-TATE	The intervention consists of an intravenous injection of the radiopharmaceutical 68Ga-DOTA-TATE and a physiological saline flush, followed 45-90 minutes later by a PET/CT image acquisition.

Timeline

• Start date: 2020-01-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-04-19
• Last updated: 2024-07-18

Locations

2 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study