LightPathTM Imaging System for Ex-vivo Assessment of Margin and Lymph Node Status in Breast Cancer Surgical Specimens

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02037269
• Lead Sponsor: Lightpoint Medical Limited

Brief Summary

This study is a prospective, cross-sectional observational single centre study to assess the feasibility of intra-operative Cerenkov Luminescence Imaging (CLI) of breast cancer wide local excision (WLE) specimens and dissected lymph nodes. The samples will be imaged using the LightPathTM Imaging System. The LightPathTM Imaging System which consists of a light-tight box on which are mounted an ultra-sensitive lens and radiation-shielded camera. This study will measure the correlation between margin status of the WLE specimen and the metastatic status of dissected lymph nodes as determined by the LightPathTM Imaging System and by histopathology. This is a pilot study to assess feasibility before proceeding to a pivotal study to evaluate the benefits of the LightPathTM Imaging System in clinical practice.

Detailed Description

Subject's blood glucose level will be measured on the day of surgery. Subjects with a blood glucose level \< 12 mmol/l receive an intravenous injection of 5 MBq/kg, up to a maximum 300 MBq of 18F-fluorodeoxyglucose (18F-FDG) prior to surgery. Breast cancer surgery will be performed per standard of care. SLNB will be performed using a dose of 150 MBq technetium 99 (99mTc) nanocolloid and patent blue dye. The resected WLE specimen and lymph nodes will be imaged in the LightPathTM Imaging System. A member of the research team who is not the operating surgeon will capture LightPathTM images intra-operatively.

Prior to CLI, the WLE specimen will be placed in a specimen holder. CLI is performed according to the LightPathTM Imaging System instructions for use. All CLI will be performed between 1 and 3 hours post injection of 18F-FDG.

The WLE specimen will then undergo standard of care histopathological analysis with a positive margin defined as either invasive carcinoma or ductal carcinoma in situ (DCIS) within 2mm of the specimen surface. Lymph nodes will also be examined according to standard of care histopathological analysis.

The CLI results will not be used to influence any surgical or clinical decision-making.

All staff in the operating theatre and the recovery area caring for the patient, and pathology staff processing surgical specimens will wear badge dosimeters. Staff handling surgical specimens will also wear ring dosimeters.

Study Timeline

• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-15
• Study Start: 2014-06
• Primary Completion: 2016-06
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-09
• Last Update Posted: 2016-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumour margin status of the Wide Local Excision specimen as determined by the LightPathTM Imaging System	Intra-operative

Secondary Outcome Measures

Name	Time	Method
Ease of use of the LightPathTM Imaging System	Intra-operative
Metastatic status of dissected lymph nodes as determined by the LightPathTM Imaging System	Intra-operative
Radiation dosimetry to operating theatre, recovery area and pathology staff	Up to 24 hours after injection of radiopharmaceutical

Trial Locations

Locations (1)

Guy's Hospital; 🇬🇧 London, United Kingdom