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Completed

NCT Number: NCT02151097

PRIME - PRostate Imaging for Margin Evaluation

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.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University College Hospital London

London, NW1 2BU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Lightpoint Medical Limited

Industry

Collaborators

  • University College London Hospitals
  • University College, London

Registry information

Official study title

A Feasibility Study to Evaluate 18F-choline Cerenkov Luminescence Imaging for Measuring Margin Status in Radical Prostatectomy Specimens

Acronym: PRIME

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 30, 2014
Registry last updated
Jun 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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