Recruiting
Phase 3

68Ga-DOTA-TATE

Sponsor:

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Code:

NCT04847505

Conditions

Neuroendocrine Tumors

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

68Ga-DOTA-TATE

Study Details

Brief 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

Study ID

NCT04847505

Start date

Jan 1, 2020

Status verified date

Jul, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 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-depth discussion with the treating physicians and the patient. In this context, any clinical situation in which the patient's life would be at stake by excluding her from the study would be considered. The conditions to decide whether to include the patient would be:

  • Severe medical condition involving the life of the pregnant woman and/or the fetus;
  • Existing treatments that are ineffective or may present toxicity to the woman 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 of the examination, which may include termination of pregnancy or premature delivery;
  • Documented discussion with the treating team and the patient;
  • Patient agrees.

Study Design

Enrollment

5000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Safety profile of 68Ga-DOTA-TATE [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Stéphanie Dubreuil

819-346-1110Stephanie.Dubreuil2@usherbrooke.ca

Locations

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

Recruiting

Montréal, Quebec, Canada, H3T 1E2

Contacts

Gad Abikhzer, MD

514-340-8222gad101@hotmail.com

CHUS

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Stéphanie Dubreuil

819-346-1110Stephanie.Dubreuil2@Usherbrooke.ca

Principal Investigator:

Éric Turcotte, MD

More Information

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Last update posted

Jul 18, 2024

Last verified

Jul, 2024

Keywords

  • 68Ga-DOTA-TATE
  • PET imaging
  • Pragmatic study
  • Neuroendocrine tumors (NET)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre de recherche du Centre hospitalier universitaire de Sherbrooke on 2024-07-18.