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PRIME - PRostate Imaging for Margin Evaluation

NCT02151097 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7

Last updated 2016-06-23

No results posted yet for this study

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

Sponsors & Collaborators

  • University College London Hospitals

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • Lightpoint Medical Limited

    lead INDUSTRY

Principal Investigators

  • Sheryl O'Farrell, PhD · Head of Clinical Development, Lightpoint Medical

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02151097 on ClinicalTrials.gov