68Ga-DOTA-TATE PET/CT Imaging in NETs
ConditionNeuroendocrine Tumors
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCentre de recherche du Centre hospitalier universitaire de Sherbrooke
About this trial
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).
Eligibility criteria
Qualifiers
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)
Disqualifiers
*Pregnancy (not an absolute exclusion). See below*.
Patient refusal to participate.
Prior severe anaphylactic reaction to DOTA-TATE or somatostatin analogs.
Severe medical condition involving the life of the pregnant woman and/or the fetus;
Trial design
Treatments tested in this trial
- 68Ga-DOTA-TATE
Treatment groups
5,000 Participants
are divided into 1 treatment groupSponsors and collaborators
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Lead sponsor
Université de Sherbrooke
Collaborator
Jewish General Hospital
Collaborator
Source ClinicalTrials.gov