PRIME - PRostate Imaging for Margin Evaluation
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This study is a prospective, single-centre feasibility study to evaluate the use of intra-operative Cerenkov Luminescence Imaging (CLI) of prostatectomy specimens to determine margin status.
Subjects will receive an intravenous injection of 370 Mega Becquerel (MBq) of 18F-choline prior to routine, elective radical prostatectomy. The surgery will be performed according to standard-of-care. The resected prostatectomy specimens will be imaged using the LightPathTM Imaging System, consisting of a light-tight box containing an ultra-sensitive lens and Electron Multiplying Charged-Coupled Device (EMCCD) camera.
This study will measure the agreement between margin status of the prostatectomy specimen as determined by CLI and by histopathology (reference method). This study will assess feasibility before proceeding to a pivotal study to evaluate the benefits of the LightPathTM Imaging System in clinical practice.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| High risk prostate cancer 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. |
Outcome Measures
Primary Outcome Measures
- Margin status of prostatectomy specimen as determined by the LightPathTM Imaging System [Intra-operative]
Use of the LightPathTM Imaging System will be examined in order to assess the feasibility of using CLI for determining margin status intraoperatively.
Secondary Outcome Measures
- The agreement between margin status as determined by CLI and histopathology [Intra and immediate post-operative]
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.
Other Outcome Measures
- Radiation dosimetry to staff [Intra and immediate post-operative]
Radiation dosimetry results will be used to assess the feasibility of following routine procedures for care of patients and handling of surgical specimens in patients undergoing prostatectomy following administration of 18F-choline.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Patients undergoing radical prostatectomy
Exclusion Criteria:
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Known hypersensitivity to 18F-choline
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Patients currently taking colchicine
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Prior therapy for prostate cancer (e.g. focal therapy)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University College Hospital London | London | United Kingdom | NW1 2BU |
Sponsors and Collaborators
- Lightpoint Medical Limited
- University College London Hospitals
- University College, London
Investigators
- Study Director: Sheryl O'Farrell, PhD, Head of Clinical Development, Lightpoint Medical
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LPM-003