CLI and FAR for Intraoperative Margin Assessment

Trial Title: CLI and FAR for Intraoperative Margin Assessment

NCT ID: NCT05496101

Condition: Breast Cancer Female

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Intraoperative CLI + FAR LightPath imaging with comparator-Standard-of-care histopathology (gold standard)

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Intraoperative CLI + FAR LightPath imaging
Description: 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
Arm group label: Breast Cancer undergoing BCS

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.

Criteria for eligibility:
Criteria:
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

Gender: Female

Gender based: Yes

Gender description: Biological representation

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Guy's and St Thomas NHS Trust

Address:
City: London
Zip: SE19RT
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Arnie Purushotham

Phone: 0207188188

Phone ext: 3027

Start date: November 21, 2022

Completion date: December 31, 2024

Lead sponsor:
Agency: King's College London
Agency class: Other

Source: King's College London

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05496101