NCT05228106 68Ga-PSMA-617 PET/CT for PSMA-expressing Tumor: a Pragmatic Study
| NCT ID | NCT05228106 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre de recherche du Centre hospitalier universitaire de Sherbrooke |
| Condition | Solid Cancers |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2022-01-21 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2022-01-21 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 .
Contact & Investigator
Éric E Turcotte, MD
PRINCIPAL INVESTIGATOR
Université de Sherbrooke, Centre de Recherche du CHUS
Frequently Asked Questions
Who can join the NCT05228106 clinical trial?
This trial is open to participants of all sexes, studying Solid Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05228106 currently recruiting?
Yes, NCT05228106 is actively recruiting participants. Contact the research team at Stephanie.Dubreuil2@usherbrooke.ca for enrollment information.
Where is the NCT05228106 trial being conducted?
This trial is being conducted at Sherbrooke, Canada.
Who is sponsoring the NCT05228106 clinical trial?
NCT05228106 is sponsored by Centre de recherche du Centre hospitalier universitaire de Sherbrooke. The principal investigator is Éric E Turcotte, MD at Université de Sherbrooke, Centre de Recherche du CHUS. The trial plans to enroll 1,000 participants.
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