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

NCT04847505 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5000

Last updated 2024-07-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Université de Sherbrooke

    collaborator OTHER

  • Jewish General Hospital

    collaborator OTHER

  • Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    lead OTHER

Principal Investigators

  • Éric E Turcotte, MD · Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04847505 on ClinicalTrials.gov