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

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Status and phase: Enrolling; Phase 3

Conditions: Neuroendocrine Tumors

Treatments: Diagnostic Test: 68Ga-DOTA-TATE

Study type: Interventional

Funder types: Other

Identifiers

NCT04847505

CIMS-2019-02

Details and patient eligibility

About

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).

Enrollment: 5,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5,000 participants in 1 patient group

Neuroendocrine cancer patients

Experimental group

Description:

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.

Treatment:

Diagnostic Test: 68Ga-DOTA-TATE