Recruiting

68Ga-PSMA-617

Sponsor:

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Code:

NCT05228106

Conditions

Solid Cancers

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

[68Ga]-PSMA-617

Study Details

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.

Conditions

Solid Cancers

Study ID

NCT05228106

Start date

Jan 21, 2022

Status verified date

Feb, 2024

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 .

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

[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.

Primary outcome measure

  • Incidence of treatment-emergent adverse events (safety and tolerability) of 68Ga-PSMA-617 [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Stéphanie Dubreuil

819-346-1110Stephanie.Dubreuil2@usherbrooke.ca

Michel Paquette, PhD

819-346-1110michel.paquette@usherbrooke.ca

Locations

CHUS

Recruiting

Sherbrooke, Quebec, Canada, J1H5N4

Contacts

Éric E Turcotte, MD

819-346-1110Eric.e.turcotte@usherbrooke.ca

Stéphanie Dubreuil

819-346-1110Stephanie.dubreuil2@usherbrooke.ca

More Information

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Last update posted

Feb 7, 2024

Last verified

Feb, 2024

Keywords

  • [68Ga]-PSMA-617
  • PET imaging
  • Pragmatic study
  • PSMA-expressing cancers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre de recherche du Centre hospitalier universitaire de Sherbrooke on 2024-02-07.