Clinical Trial · NCT02151097

PRIME - PRostate Imaging for Margin Evaluation

Overview

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.

Sponsor

Lightpoint Medical

Contacts

Sheryl O'Farrell, PhD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT02151097

Drug / Compound

choline

Isotope(s):
Target(s):
  • Phospholipid Metabolism
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Patients undergoing radical prostatectomy

Exclusion

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