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

NCT04847505 | Recruiting Phase 3 FDA Drug

• 1 other identifier: CIMS-2019-02
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety profile of 68Ga-DOTA-TATE

  Following the injection, the patient will be explicitly reminded of possible symptoms and undesirable events. The patient will be advised to inform the study personnel of the occurrence of any events, at the most opportune time. The patient will be instructed to call the local nuclear medicine study coordinator for any undesirable event that may occur for 48 hours after the PET/CT scan. Safety will be assessed by compiling all reported adverse events. Adverse events reported by patients or observed by the investigator will be recorded in the patients' CRFs, the AE database, and reported to the research manager.

  5 years

Secondary Outcomes (2)

• Generate clinical information on the impact of 68Ga-DOTA-TATE for NET patient management

  5 years

• Instigate the routine standard-of-care use of 68Ga-DOTA-TATE for NET patients

  5 years

Study Arms (1)

Neuroendocrine cancer patients

EXPERIMENTAL

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.

Diagnostic Test: 68Ga-DOTA-TATE

Interventions

68Ga-DOTA-TATE 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.

Also known as: Netspot

Neuroendocrine cancer patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 less than 18 years of age)

You may not qualify if:

• Patient refusal to participate.
• 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.

Sponsors & Collaborators

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: lead
• Université de Sherbrooke: collaborator
• Jewish General Hospital: collaborator

Study Sites (2)

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

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Éric E Turcotte, MD

  Centre de recherche du Centre hospitalier universitaire de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie Dubreuil

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the clinical research, CIMS, CHUS

Model Details: Neuroendocrine cancer patients, regardless of the primary tumor origin, are eligible. Recruitment is across all Canada but the examination is performed at the primary site of the study. The safety profile of the procedure will be assessed, and integration of 68Ga-DOTA-TATE will be integrated in the routine clinical practice.

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 19, 2021
• Study Start: January 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

CA (2)