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RECRUITING
NCT05228106

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

Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2022-01-21

Completion Date

2027-01-31

Last Updated

2024-02-07

Healthy Volunteers

No

Conditions

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.

Locations (1)

CHUS

Sherbrooke, Quebec, Canada