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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    5000
  • sponsor
    Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Updated on 4 October 2022

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).

Details
Condition Neuroendocrine Tumors
Treatment 68Ga-DOTA-TATE
Clinical Study IdentifierNCT04847505
SponsorCentre de recherche du Centre hospitalier universitaire de Sherbrooke
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

_Pregnancy (not an absolute exclusion). See below_
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
Clear my responses

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