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LightPathTM Imaging System for Ex-vivo Assessment of Margin and Lymph Node Status in Breast Cancer Surgical Specimens

NCT02037269 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2016-08-10

No results posted yet for this study

Summary

This study is a prospective, cross-sectional observational single centre study to assess the feasibility of intra-operative Cerenkov Luminescence Imaging (CLI) of breast cancer wide local excision (WLE) specimens and dissected lymph nodes. The samples will be imaged using the LightPathTM Imaging System. The LightPathTM Imaging System which consists of a light-tight box on which are mounted 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 Imaging System in clinical practice.

Conditions

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    collaborator OTHER

  • King's College London

    collaborator OTHER

  • Lightpoint Medical Limited

    lead INDUSTRY

Principal Investigators

  • Anand D Purushotham, MBBS FRCS MD · King's College London

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-06-30
Completion
2016-07-31

Countries

  • United Kingdom

Study Locations

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Diseases
Companies

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 NCT02037269 on ClinicalTrials.gov