CLI and FAR for Intraoperative Margin Assessment

Phase 2

Recruiting

• Conditions: Breast Cancer Female
• Interventions: Procedure: Intraoperative CLI + FAR LightPath imaging

• Registration Number: NCT05496101
• Lead Sponsor: King's College London

Brief 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.

Study Timeline

• Study First Submitted: 2022-04-29
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Study Start: 2022-11-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• • Female subjects ≥18 years of age with a diagnosis of invasive breast cancer scheduled to undergo BCS

  • Subjects who are able to give voluntary, written informed consent to participate in this study
  • Subjects who are able to understand this study and are willing to complete all the study assessments
  • Female subjects of childbearing age must have a negative pregnancy test (by Beta human chorionic gonadotrophin (β-HCG) qualitative analysis) or must have had a history of a surgical sterilisation or must give history of no menses in the past twelve months.

Exclusion Criteria

• Subjects who have had surgery to the ipsilateral breast in the past 12 months
• Subjects who have had radiotherapy to the ipsilateral breast
• Subjects who have a known hypersensitivity to 18F-FDG
• Subjects who are pregnant or lactating
• Subjects who have an existing medical condition that would compromise their participation in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breast Cancer undergoing BCS	Intraoperative CLI + FAR LightPath imaging	Intraoperative CLI + FAR LightPath imaging compared with Standard-of-care histopathology (gold standard)

Primary Outcome Measures

Name	Time	Method
Margin status of WLE specimens	complete surgical procedure	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. 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.

Secondary Outcome Measures

Name	Time	Method
• Agreement between margin status of cavity shavings as determined by intraoperative CLI + FAR LightPath imaging and post-operative histopathology.	complete surgical procedure	• Re-operation rate within the study cohort compared to general breast cancer population undergoing a WLE.

Trial Locations

Locations (1)

Guy's and St Thomas NHS Trust; 🇬🇧 London, United Kingdom