Actively Recruiting

Phase 3
All Genders
NCT04847505

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

Led by Centre de recherche du Centre hospitalier universitaire de Sherbrooke · Updated on 2024-07-18

5000

Participants Needed

2

Research Sites

313 weeks

Total Duration

On this page

Sponsors

C

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Lead Sponsor

U

Université de Sherbrooke

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 under 18 years old
Not Eligible

You will not qualify if you...

  • Pregnancy (not an absolute exclusion; requires detailed discussion and patient agreement)
  • Patient refusal to participate
  • Prior severe anaphylactic reaction to DOTA-TATE or somatostatin analogs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Centre Intégré Universitaire de Santé et des Services Sociaux du Centre de l'Ouest de Montréal - Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

Actively Recruiting

2

CHUS

Sherbrooke, Quebec, Canada, J1H 5N4

Actively Recruiting

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Research Team

S

Stéphanie Dubreuil

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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