The Breast Surgery BetaScope and Specimen Analyser study, Version 1
Research type
Research Study
Full title
A pilot study to evaluate molecular imaging using a BetaScope and a Specimen Analyser for determining margin and lymph node status during breast conserving surgery in women with breast cancer
IRAS ID
155878
Contact name
Morten Harboe
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, months, days
Research summary
This study will look at the feasibility of using two new medical devices to detect breast cancer in real-time during surgery, something which potentially could reduce the need for repeat operations. Patients are injected with a radioactive tracer (18F-FDG) before surgery and the instruments are used to detect this tracer during the operation. The total duration of patient participation in the study is one screening visit and one surgery visit.
The first medical device is called the Cerenkov Luminescence Imaging (CLI) specimen analyser. Previous research has shown that CLI can detect cancer and might be useful in helping surgeons to know if all cancer has been removed. In this study the CLI specimen analyser will be used to examine tumours and lymph nodes after they have been surgically removed from the body.
The second medical device is called the BetaScope beta particle detector. Previous research using other beta particle detectors has shown that these instruments can be used to detect cancer. In this study the BetaScope will be used to examine tumours and lymph nodes after they have been surgically removed from the body. The BetaScope will also be used to examine the area of the breast where the tumour was removed from, and the area in the armpit best suited to check if the cancer has spread from the breast.
The two devices will be used alongside but independent of each other. If the instruments indicate that not all cancer has been removed a small additional amount of tissue may be taken out. This can potentially lead to more complete removal of cancer tissue during surgery.
After surgery all removed tissue will be examined by standard histology, to check if the devices are as good as the routine tests at detecting cancer.
REC name
South East Scotland REC 02
REC reference
14/SS/1109
Date of REC Opinion
19 Dec 2014
REC opinion
Favourable Opinion