PRIME - PRostate Imaging for Margin Evaluation

NCT02151097 | Completed

• 1 other identifier: LPM-003
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms

Keywords

Prostatectomy; Prostate cancer; Cerenkov Luminescence Imaging

Outcome Measures

Primary Outcomes (1)

• Margin status of prostatectomy specimen as determined by the LightPathTM Imaging System

  Use of the LightPathTM Imaging System will be examined in order to assess the feasibility of using CLI for determining margin status intraoperatively.

  Intra-operative

Secondary Outcomes (1)

• The agreement between margin status as determined by CLI and histopathology

  Intra and immediate post-operative

Other Outcomes (1)

• Radiation dosimetry to staff

  Intra and immediate post-operative

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Known hypersensitivity to 18F-choline
• Patients currently taking colchicine
• Prior therapy for prostate cancer (e.g. focal therapy)

Sponsors & Collaborators

• Lightpoint Medical Limited: lead
• University College London Hospitals: collaborator
• University College, London: collaborator

Study Sites (1)

University College Hospital London

London, NW1 2BU, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Sheryl O'Farrell, PhD

  Head of Clinical Development, Lightpoint Medical

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 30, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 23, 2016

Record last verified: 2016-03

Locations

GB (1)