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

August 9, 2016 updated by: Lightpoint Medical Limited

A Pilot Study to Evaluate Cerenkov Luminescence Imaging for Measuring Margin and Lymph Node Status in Breast Cancer Surgical Specimens

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female patients ≥30 years of age with known breast cancer scheduled for breast-conserving surgery (BCS) +/- sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND)

Description

Inclusion Criteria

  • Females ≥30 years of age with a diagnosis of invasive breast cancer or DCIS
  • Scheduled for BCS +/- SLNB or ALND
  • Females of childbearing age must have a negative pregnancy test (by Beta HCG qualitative analysis), must have had a history of a surgical sterilisation, or must give history of no menses in past twelve months

Exclusion Criteria

  • Surgery or radiotherapy in the operated breast in the past 2 years
  • Neoadjuvant systemic therapy
  • Patients not suitable for BCS
  • Blood glucose level ≥ 12 mmol/l on the day of surgery
  • Known hypersensitivity to 18F-FDG
  • Any patient who is pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
All participants
Female patients ≥30 years of age with known breast cancer scheduled for breast-conserving surgery (BCS) +/- sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumour margin status of the Wide Local Excision specimen as determined by the LightPathTM Imaging System
Time Frame: Intra-operative
Intra-operative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lightpoint Medical Limited

Collaborators

King's College London
Guy's and St Thomas' NHS Foundation Trust

Investigators

  • Principal Investigator: Anand D Purushotham, MBBS FRCS MD, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 14, 2014

First Posted (Estimate)

January 15, 2014

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPM-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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