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The Breast Surgery EnLight and LightPath Imaging System Study

NCT02151071 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-09-07

No results posted yet for this study

Summary

This study will correlate the resection margin status of the breast cancer tumour (WLE specimen), cavity shavings (if any) and breast cavity, and the metastatic status of axillary lymph nodes as determined by EnLight, LightPath, and histopathology. This is a pilot study to assess feasibility before proceeding to a pivotal study to evaluate the use of these imaging systems in clinical practice.

Conditions

  • Breast Neoplasms

Interventions

DEVICE

EnLight

The Lightpoint EnLight beta particle detector is an investigational non CE-marked medical device

DEVICE

LightPath

The LightPath Imaging System is an investigational non CE-marked in vitro diagnostic device

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 · Guy's and St Thomas' NHS Foundation Trust

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2018-09-30
Completion
2019-09-30

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT02151071 on ClinicalTrials.gov