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

NCT05228106 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-02-07

No results posted yet for this study

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.

Conditions

  • Solid Cancers

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.

Sponsors & Collaborators

  • Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    lead OTHER

Principal Investigators

  • Éric E Turcotte, MD · Université de Sherbrooke, Centre de Recherche du CHUS

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-21
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05228106 on ClinicalTrials.gov