CLI and FAR for Intraoperative Margin Assessment (CLI-FAR)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Female
• Intervention / Treatment: Procedure: Intraoperative CLI + FAR LightPath imaging

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Arnie Purushotham; Phone Number: 3027 0207188188; Email: Arnie.purushotham@kcl.ac.uk
• Study Contact Backup: Name: Belul Shifa; Phone Number: 80743 02071880743; Email: belul.shifa@gstt.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SE19RT
    • Recruiting
    • Guy's and St Thomas NHS Trust
    • Contact: Arnie Purushotham; Phone Number: 3027 0207188188

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Breast Cancer undergoing BCS; Intraoperative CLI + FAR LightPath imaging compared with Standard-of-care histopathology (gold standard)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Margin status of WLE specimens	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.	complete surgical procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: King's College London

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRAS 314460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No