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.

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
CHUS
RECRUITING
Sherbrooke
Contact Information
Primary
Stéphanie Dubreuil
Stephanie.Dubreuil2@usherbrooke.ca
819-346-1110
Backup
Michel Paquette, PhD
michel.paquette@usherbrooke.ca
819-346-1110
Time Frame
Start Date: 2022-01-21
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 1000
Treatments
Patients eligible for [68Ga]-PSMA-617-PET
All cancer patients referred by their physician and fulfilling the eligibility criteria across Canada can be recruited to the primary site of the study. Patients will be injected intravenously with a \[68Ga\]-PSMA-617 dose calculated depending on the characteristics of the PET tomograph and patient weight (maximum 370 MBq). 60-90 minutes following injection, patients will be imaged in a PET/CT scanner. Images will be analyzed by a trained nuclear medicine physician. Safety profile, eventual adverse effects, false positives, false negatives and any abnormal biodistribution of the radiotracer will be monitored and analysed.
Related Therapeutic Areas
Sponsors
Leads: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

This content was sourced from clinicaltrials.gov