Clinical trial · Observational
PRIME - PRostate Imaging for Margin Evaluation
A Feasibility Study to Evaluate 18F-choline Cerenkov Luminescence Imaging for Measuring Margin Status in Radical Prostatectomy Specimens
- 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 study will evaluate the feasibility of using intra-operative Cerenkov Luminescence Imaging (CLI) of prostatectomy specimens to determine tumour margin status. The samples will be imaged using the LightPathTM Imaging System which consists of a light-tight box containing an ultra-sensitive lens and radiation-shielded camera. This study will measure the correlation between margin status of the WLE specimen and the metastatic status of dissected lymph nodes as determined by the LightPathTM Imaging System and by histopathology. This is a pilot study to assess feasibility before proceeding to a pivotal study to evaluate the benefits of the LightPathTM system in clinical practice.
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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- High risk prostate cancer
- description
- Men ≥18 years of age diagnosed with high risk prostate cancer, defined as clinical stage ≥T2c, or Prostate Specific Antigen (PSA)\>20 ng/ml, or Gleason Score 8-10, scheduled to have radical prostatectomy.
Primary outcomes (1)
- measure
- Margin status of prostatectomy specimen as determined by the LightPathTM Imaging System
- timeFrame
- Intra-operative
- description
- Use of the LightPathTM Imaging System will be examined in order to assess the feasibility of using CLI for determining margin status intraoperatively.
Secondary outcomes (1)
- measure
- The agreement between margin status as determined by CLI and histopathology
- timeFrame
- Intra and immediate post-operative
- description
- Tumour margin status of prostatectomy specimens as determined by CLI and routine histopathology analysis will be compared in order to assess the performance of the LightPathTM Imaging System for determining margin status intraoperatively.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men ≥18 years of age diagnosed with high risk prostate cancer, defined as clinical stage ≥T2c, or PSA\>20 ng/ml, or Gleason Score 8-10. * Patients undergoing radical prostatectomy Exclusion Criteria: * Known hypersensitivity to 18F-choline * Patients currently taking colchicine * Prior therapy for prostate cancer (e.g. focal therapy)
References
Publications (0)
Data not yet available