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The LightPath® Breast Cancer Study

NCT02666079 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2018-06-20

No results posted yet for this study

Summary

This study is a prospective, single arm, multi-centre study to evaluate the intra-operative use of the LightPath® Imaging System for the assessment of tumour margin status compared to hospital standard of care histopathology in wide local excision (WLE) for breast cancer

The intraoperative 18F-fluorodeoxyglucose (18F-FDG) LightPath® Images will be used to inform the surgeons about detectable residual cancer, in an attempt to achieve better guided cancer surgery and complete tumour excision with clear WLE resection margins.

Study sites will use the local criteria considered standard of care to guide decisions to act on positive margins.

In the LightPath® arm the resection margin status of the WLE specimen, cavity shavings (if any) and the metastatic status of axillary (sentinel) lymph nodes as measured with the LightPath® Imaging System will be compared with histopathology results.

Conditions

Interventions

DEVICE

LightPath® Imaging System.

Intra-operative use of the LightPath® Imaging System.

Sponsors & Collaborators

Principal Investigators

  • Qamar B Akbar, MSc · Clinical Project Manager

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2018-11-30
Completion
2018-12-31

Countries

  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT02666079 on ClinicalTrials.gov