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

NCT ID: NCT04847505

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 5000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2025-12-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

68Ga-DOTA-TATE

Intervention Type: DIAGNOSTIC_TEST

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.

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Netspot

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Sherbrooke

OTHER

Sponsor Role: collaborator

Jewish General Hospital

OTHER

Sponsor Role: collaborator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Dr Éric E Turcotte, MD

Head of the clinical research, CIMS, CHUS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Éric E Turcotte, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Locations

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

Montreal, Quebec, Canada

Site Status: RECRUITING

CHUS

Sherbrooke, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Stéphanie Dubreuil

Role: CONTACT

Stephanie.Dubreuil2@usherbrooke.ca

819-346-1110 ext. 16617

Facility Contacts

Gad Abikhzer, MD

Role: primary

gad101@hotmail.com

514-340-8222

Stéphanie Dubreuil

Role: primary

Stephanie.Dubreuil2@Usherbrooke.ca

819-346-1110 ext. 16617

Other Identifiers

CIMS-2019-02

Identifier Type: -

Identifier Source: org_study_id