Status:
RECRUITING
68Ga-DOTA-TATE PET/CT Imaging in NETs
Lead Sponsor:
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborating Sponsors:
Université de Sherbrooke
Jewish General Hospital
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- \*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.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT04847505
Start Date
January 1 2020
End Date
December 31 2025
Last Update
July 18 2024
Active Locations (2)
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1
Centre Intégré Universitaire de Santé et des Services Sociaux du Centre de l'Ouest de Montréal - Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
2
CHUS
Sherbrooke, Quebec, Canada, J1H 5N4