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Recruiting NCT05228106

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

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Trial Parameters

Condition Solid Cancers
Sponsor Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Study Type OBSERVATIONAL
Phase N/A
Enrollment 1,000
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2022-01-21
Completion 2027-01-31
Interventions
[68Ga]-PSMA-617

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Brief 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 Criteria

Inclusion Criteria: 1. Clinical requisition for a 68Ga-PSMA-617 PET/CT signed by a referring doctor; 2. Patients with suspected, proven or prior tumor expressing PSMA; 3. Informed consent by patient. Exclusion Criteria: 1. Patient refusal to participate; 2. Prior severe anaphylactic reaction to 68Ga-PSMA-617 .

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