CairnSurgical Breast Cancer Locator (BCL) System
Research type
Research Study
Full title
Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
IRAS ID
310195
Contact name
James Harvey
Contact email
Sponsor organisation
CairnSurgical
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
A major problem for surgeons when they do breast conserving surgery is that cancer cells may be found at the edge of the breast tissue specimen that is removed. The finding of breast cancer cells at the edge usually requires another surgery to remove additional tissue.
This study is recruiting participants that have been diagnosed with invasive breast cancer or breast cancer in the breast milk ducts (ductal carcinoma in situ) and are planning to have breast conserving surgery as part of treatment.
The primary purpose of the study is to determine whether a device called the Breast Cancer Locator (BCL) System can be used during surgery to decrease the chance of finding cancer cells at the edge of the specimen. The study is designed to determine if the BCL System is safe, effective, and superior to the standard of care (wire localization). The BCL is a plastic bra-like form that gives the study doctor information about the location of the cancer in the participant's breast. The location information is derived from images obtained from MRI. The MRI is obtained several days before surgery with the participant lying flat on their back, as they are on an operating room table. The BCL is then custom made using 3-dimensional (3D) printing technology.
The main outcome measure of this study is to compare whether cancer cells have been identified at the edge of the specimen when one has surgery with the BCL System vs standard of care wire localization. Additionally, the study compares the total amount of breast tissue removed, the surgery time, complications that may occur during or after surgery, and cost of care between participants that are treated with the BCL System and those that receive the standard of care wire localization.
REC name
London - Dulwich Research Ethics Committee
REC reference
22/LO/0487
Date of REC Opinion
2 Sep 2022
REC opinion
Further Information Favourable Opinion