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NCT05228106Recruiting

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

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.

Source: ClinicalTrials.gov · Last updated 7 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1000 (estimated)
First submitted
27 Jan 2022
Start date
21 Jan 2022
Primary completion date
31 Jan 2027
Lead sponsor
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
NCT number
NCT05228106

What you commit to

  • Study type: Observational
  • Planned participants: 1000
  • From 21 Jan 2022 to the primary completion date, 31 Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior severe anaphylactic reaction to 68Ga-PSMA-617 .

Other

  • Patient refusal to participate;

Who the study is looking for

  • 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.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHUS
Coordinator of this site? Confirm its status
SherbrookeCanadaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.