Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
7 participants
OBSERVATIONAL
2014-11-30
2016-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing radical prostatectomy
Exclusion Criteria
* Patients currently taking colchicine
* Prior therapy for prostate cancer (e.g. focal therapy)
18 Years
MALE
No
Sponsors
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University College London Hospitals
OTHER
University College, London
OTHER
Lightpoint Medical Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Sheryl O'Farrell, PhD
Role: STUDY_DIRECTOR
Head of Clinical Development, Lightpoint Medical
Locations
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University College Hospital London
London, , United Kingdom
Countries
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Other Identifiers
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LPM-003
Identifier Type: -
Identifier Source: org_study_id
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