RecruitingNCT05228106

68Ga-PSMA-617 PET/CT for PSMA-expressing Tumor: a Pragmatic Study

Pragmatic Study on the Use of 68Ga-PSMA-617 PET/CT Imaging as a Standard of Care to Influence Clinical Management of Tumors Overexpressing PSMA.

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Enrollment

1,000 participants

Start Date

Jan 21, 2022

Study Type

OBSERVATIONAL

Conditions

Solid Cancers

Summary

This project aims to monitor the innocuity/safety profile of cyclotron-produced \[68Ga\]-PSMA-617 PET imaging in PSMA-expressing cancers. It is a single-site, pragmatic, non-randomized and open-label study, with no control group. Although prostate cancers constitute the usual recommended population for this PET modality, recent evidences suggest that most solid tumors express substantial amount of PSMA in their neovasculature. As such, all cancers (excluding non-solid cancers) will be eligible for \[68Ga\]-PSMA-617 PET imaging in this trial, for as long as their tumors express PSMA. This study also aims to instigate the use of \[68Ga\]-PSMA-617 in the routine standard-of-care for detection and follow-up of eligible cancers. FInally, this project seeks to gather information about the impact on patient management this novel PET modality will have over the current standard-of-care.

Eligibility

Inclusion Criteria3

Clinical requisition for a 68Ga-PSMA-617 PET/CT signed by a referring doctor;
Patients with suspected, proven or prior tumor expressing PSMA;
Informed consent by patient.

Exclusion Criteria2

Patient refusal to participate;
Prior severe anaphylactic reaction to 68Ga-PSMA-617 .

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TEST[68Ga]-PSMA-617

The intervention consists of an intravenous injection of the radiopharmaceutical \[68Ga\]-PSMA-617 and a physiological saline flush, followed 60-90 minutes later by a PET/CT image acquisition.