NCT05496101

CLI and FAR for Intraoperative Margin Assessment

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: King's College London · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
PROCEDURE	Intraoperative CLI + FAR LightPath imaging	Imaging System: The LightPath Imaging System is an in vitro diagnostic device which has CE mark in Europe, in line with In Vitro Diagnostic Medical Devices 98/79/EC (post marketing study). Radiopharmaceutical: 18F-FDG is a routinely used Positron Emission Tomography (PET) / Computed Tomography (CT) radiopharmaceutical

Timeline

• Start date: 2022-11-21
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-08-11
• Last updated: 2024-02-05

Locations

1 site across 1 country: United Kingdom