CLI and FAR for Intraoperative Margin Assessment

NCT05496101 | Recruiting Phase 2 DMC

• 1 other identifier: IRAS 314460
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• • Agreement between margin status of cavity shavings as determined by intraoperative CLI + FAR LightPath imaging and post-operative histopathology.

  complete surgical procedure

Study Arms (1)

Breast Cancer undergoing BCS

OTHER

Intraoperative CLI + FAR LightPath imaging compared with Standard-of-care histopathology (gold standard)

Procedure: Intraoperative CLI + FAR LightPath imaging

Interventions

Intraoperative CLI + FAR LightPath imaging PROCEDURE

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

Breast Cancer undergoing BCS

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biological representation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

Guy's and St Thomas NHS Trust

London, SE19RT, United Kingdom

RECRUITING

Central Study Contacts

Arnie Purushotham

CONTACT

0207188188; Arnie.purushotham@kcl.ac.uk

Belul Shifa

CONTACT

02071880743; belul.shifa@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intraoperative CLI + FAR LightPath imaging with comparator-Standard-of-care histopathology (gold standard)

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: August 11, 2022
• Study Start: November 21, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)