CLI and FAR for Intraoperative Margin Assessment version 1.0
Research type
Research Study
Full 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)
IRAS ID
314460
Contact name
A.D. Purushotham
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 31 days
Research 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.
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.REC name
London - Chelsea Research Ethics Committee
REC reference
22/LO/0524
Date of REC Opinion
23 Sep 2022
REC opinion
Further Information Favourable Opinion