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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
Sponsor:
Collaborators:
University College London Hospitals
University College, London
Information provided by (Responsible Party):
Lightpoint Medical Limited

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
Prostatic Neoplasms

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 Type : Observational
Actual Enrollment : 7 participants
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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, undergoing radical prostatectomy.
Criteria

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)

Information from the National Library of Medicine

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


Locations
United Kingdom
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

Responsible Party: Lightpoint Medical Limited
ClinicalTrials.gov Identifier: NCT02151097     History of Changes
Other Study ID Numbers: LPM-003
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: March 2016

Keywords provided by Lightpoint Medical Limited:
Prostatectomy
Prostate cancer
Cerenkov Luminescence Imaging

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases