Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Cancers | Malignant Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]-PSMA-617 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients eligible for [68Ga]-PSMA-617-PET
- description
- 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.
- interventionNames
- Diagnostic Test: [68Ga]-PSMA-617
Primary outcomes (1)
- measure
- Incidence of treatment-emergent adverse events (safety and tolerability) of 68Ga-PSMA-617
- timeFrame
- 5 years
- description
- Following the injection, the patient will be explicitly reminded of possible symptoms and undesirable events. The patient will be advised to inform the study personnel of the occurrence of any events, at the most opportune time. The patient will be instructed to call the local nuclear medicine study coordinator for any undesirable event that may occur for 48 hours after the PET/CT scan. Safety will be assessed by compiling all reported adverse events. Adverse events reported by patients or observed by the investigator will be recorded in the patients' CRFs, the AE database, and reported to the research manager.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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 .
References
Publications (0)
Data not yet available