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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04847505
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Éric E Turcotte, MD
Principal Investigator Affiliation	Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroendocrine Tumors

Arms & Interventions

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

Diagnostic Test: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHUS, Sherbrooke, Quebec, Canada

Status

Recruiting

Address

CHUS

Sherbrooke, Quebec, J1H 5N4

Site Contact

Stéphanie Dubreuil

Stephanie.Dubreuil2@Usherbrooke.ca

819-346-1110 #16617

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