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

Last updated: July 16, 2024
Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Overall Status: Active - Recruiting

Phase

3

Condition

Abdominal Cancer

Digestive System Neoplasms

Carcinoid Syndrome And Carcinoid Tumours

Treatment

68Ga-DOTA-TATE

Clinical Study ID

NCT04847505
CIMS-2019-02
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. Patients with suspected or proven tumors expressing somatostatin receptors

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

Exclusion

Exclusion Criteria:

  1. Pregnancy (not an absolute exclusion). See below.

  2. Patient refusal to participate.

  3. Prior severe anaphylactic reaction to DOTA-TATE or somatostatin analogs.

  • In the case of a diagnostic procedure in a patient who is or may be pregnant,the principle of benefits-disadvantages would be applied following an in-depthdiscussion with the treating physicians and the patient. In this context, anyclinical situation in which the patient's life would be at stake by excludingher from the study would be considered. The conditions to decide whether toinclude the patient would be:
  • Severe medical condition involving the life of the pregnant woman and/orthe fetus;
  • Existing treatments that are ineffective or may present toxicity to thewoman and/or fetus;
  • High clinical suspicion of a somatostatin receptor overexpressing tumour;
  • Negative, indeterminate or contraindicated first-line imaging tests;
  • Therapeutic gesture considered during pregnancy based on the results ofthe examination, which may include termination of pregnancy or prematuredelivery;
  • Documented discussion with the treating team and the patient;
  • Patient agrees.

Study Design

Total Participants: 5000
Treatment Group(s): 1
Primary Treatment: 68Ga-DOTA-TATE
Phase: 3
Study Start date:
January 01, 2020
Estimated Completion Date:
December 31, 2025

Connect with a study center

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

    Montréal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • CHUS

    Sherbrooke, Quebec J1H 5N4
    Canada

    Active - Recruiting

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