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CLI and FAR for Intraoperative Margin Assessment — CLI-FAR  

Breast Cancer Female Clinical Trial

Official title:
Intraoperative Assessment of Tumour Excision Margins Using the LightPath Imaging System for Cerenkov Luminescence Imaging (CLI) Combined With Flexible Autoradiography (FAR) in Women Undergoing Breast-conserving Surgery (BCS)

Clinical Trial Summary

This study is a prospective, single arm interventional study to evaluate the diagnostic accuracy of intraoperative Cerenkov luminescence imaging (CLI) plus flexible autoradiography (FAR) using the LightPath® Imaging System for intraoperative tumour margin assessment compared to post-operative standard-of-care histopathology in women undergoing breast-conserving surgery for breast cancer.

Clinical Trial Description

The intraoperative LightPath images will be used to inform the operating surgeon about potentially detectable cancer at the margins of the excised specimen in an attempt to achieve better guided cancer surgery and complete tumour excision with clear resection margins. If a positive excision margin is detected on intraoperative LightPath® images, the operating surgeon will take a cavity shaving of the corresponding margin, provided more tissue can be taken. Subsequent LightPath® imaging of the cavity shaving will inform the operating surgeon on the margin status of the shaving. If a positive excision margin is detected on intraoperative LightPath® images, the operating surgeon will take a further cavity shave of the corresponding margin, provided more tissue can be taken. The resection margin status of the WLE specimen and cavity shavings (if any), as assessed by LightPath CLI + FAR imaging will be compared with final histopathology results. A positive margin on histology will be defined as - Invasive carcinoma: positive: <1mm; negative ≥1mm - Ductal carcinoma in situ (DCIS) (if present): positive: <2mm; negative ≥2mm. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05496101
Study type Interventional
Source King's College London
Contact Arnie Purushotham
Phone 0207188188
Email Arnie.purushotham@kcl.ac.uk
Status Recruiting
Phase Phase 2
Start date November 21, 2022
Completion date December 31, 2024
View Details
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