Randomised trial of LightPath Imaging in breast cancer surgery
Research type
Research Study
Full title
A randomised, controlled, multi-centre clinical study to evaluate the outcomes following the intra-operative use of the LightPathTM Imaging System compared to standard practice in wide local excision (WLE) for breast cancer
IRAS ID
189229
Contact name
Anand D Purushotham
Contact email
Sponsor organisation
Lightpoint Medical Ltd
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
31650, ISRCTN Ref (trial submitted and in editorial curation process)
Duration of Study in the UK
6 years, 5 months, 30 days
Research summary
This study will investigate if the LightPath™ Imaging System provides more complete cancer tissue removal in women having ‘breast-conserving surgery’ for breast cancer.
Many patients have ‘breast conserving surgery’ which tries to remove all of the cancer but leave as much as possible of the breast intact. It is difficult for the surgeon to see the difference between cancer and healthy tissue, so cancer is often left undiscovered in the breast. This is a well-known problem and the LightPath™ manufactured by Lightpoint Medical Ltd, this study’s funder, attempts a solution.
LightPath™ sees cancer tissue using the same radioactive pharmaceuticals (‘radiotracers’) used in positron emission tomography (PET) to locate cancer. This study uses the radioactive sugar 18F-Fludeoxyglucose (18F-FDG), the radiotracer most commonly used for PET diagnosis of breast cancer. We expect that LightPath™ will enable surgeons to see more of the cancer tissue than they can with the naked eye. This would enable them to remove the cancer more completely during the operation so that a second re-operation becomes less likely.
To evaluate this we will determine how often women having surgery with LightPath™ (called ‘the treatment arm’) need a second operation and compare that to the number of re-operations when LightPath™ is not used (‘the control arm’). Each study patient will be randomly placed in one of the two study arms’. Before surgery a patient in the ‘treatment arm’ will be given the same dose of 18F-FDG that they would receive for a PET scan, and a higher than normal dose of another radiotracer (Technetium-99m) used as part of standard care to find cancer in the lymph nodes. All other treatment of the patients will be as standard of care. The study will also measure how much tissue is removed from the breast during surgery and the patient’s quality of life, and follow-up patients for 5 years.REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/0414
Date of REC Opinion
4 Apr 2016
REC opinion
Further Information Favourable Opinion