PRIME - PRostate Imaging for Margin Evaluation (PRIME)
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|ClinicalTrials.gov Identifier: NCT02151097|
Recruitment Status : Completed
First Posted : May 30, 2014
Last Update Posted : June 23, 2016
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||7 participants|
|Official Title:||A Feasibility Study to Evaluate 18F-choline Cerenkov Luminescence Imaging for Measuring Margin Status in Radical Prostatectomy Specimens|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
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.
- Margin status of prostatectomy specimen as determined by the LightPathTM Imaging System [ Time Frame: 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.
- The agreement between margin status as determined by CLI and histopathology [ Time Frame: 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.
- Radiation dosimetry to staff [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151097
|University College Hospital London|
|London, United Kingdom, NW1 2BU|
|Study Director:||Sheryl O'Farrell, PhD||Head of Clinical Development, Lightpoint Medical|