Clinical trial · Observational
Digital PET/CT Using [Ga-68]PSMA for Characterization of Prostate Lesions
NCT04867603CI-TRIAL-00072391completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate a radioactive diagnostic study drug, which is called Gallium-68 Prostate Specific Membrane Antigen (\[Ga-68\]PSMA) for characterization of prostate abnormalities.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [Ga-68]PSMA | Drug | — | UNRESOLVED |
| PET/CT imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Digital PET/CT using [Ga-68]PSMA
- description
- Following prostate Standard of Care MRI, eligible participants will receive a single injection of \[Ga-68\]PSMA followed by digital PET/CT imaging approximately 60 minutes later. PET/CT takes approximately 30-35 minutes, where the participant would lay still on a scanner table.
- interventionNames
- Drug: [Ga-68]PSMA
- Device: PET/CT imaging
Primary outcomes (9)
- measure
- True positive rate
- timeFrame
- During scan, up to 35 minutes
- description
- Diagnostic performance of digital PET/CT using \[Ga-68\]PSMA for characterization of prostate lesions, as measured by true-positive rate. The uptake of \[Ga-68\]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland. The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up. Subsequent histopathology will be used as the reference standard. If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have a clinical suspicion of prostate cancer defined by PI-RADS 3, 4 or 5 lesions detected on MRI as well as patients with negative prostate MRI or those with PI-RADS 1 or 2 lesions if they have continued suspicion for prostate cancer. Patients who cannot undergo MRI imaging but have a clinical suspicion for prostate cancer based on serum PSA level, family history or clinical examination (positive digital rectal examination) can also be included. * Able to tolerate PET/CT scans * Informed consent must be given and signed Exclusion Criteria: * Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks * Known allergy against Ga-68 PSMA * Prior prostate biopsy within the last 2 weeks
References
Publications (0)
Data not yet available
No reference posted for this study.