LightPath® and 68Ga-RM2 in Breast Cancer
Research type
Research Study
Full title
Evaluation of the LightPath® Imaging System and the PET tracer 68Ga-RM2 in wide local excision (WLE) for breast cancer
IRAS ID
250951
Contact name
Qamar Akbar
Contact email
Sponsor organisation
Lightpoint Medical Ltd
Eudract number
2017-003212-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
This study is a prospective, open label study to examine the performance of the LightPath® Imaging System using the PET tracer 68Ga-RM2 in patients scheduled for wide local excision (WLE) for breast cancer. The study consists of 3 groups.
Patients will be recruited into Group 1 initially. They will be injected with the 68Ga-RM2 and have a PET/CT scan. This is to determine the ideal LightPath® scan time window following injection of the 68Ga-RM2.
Once this is determined, the site will recruit a further 10 patients into Group 2. These patients will be injected and have breast surgery (as per standard practice). This group is to familiarise the site with the procedure, interpretation of the LightPath® scans, confirm the correct 68Ga-RM2 dose and timings from Group 1.
Once the site is familiar with the procedure and the site will recruit 50 patients into Group 3. Patients will be injected with the optimised 68Ga-RM2 dose and have breast surgery (as per standard care). The intra-operative 68Ga-RM2 LightPath® Images will be used to inform the surgeons about detectable remaining cancer, in an attempt to achieve better guided cancer surgery and complete tumour removal with clear WLE resection margins.
The study site will use the local criteria considered standard of care to guide decisions to act on positive margins. The LightPath® resection margin status of the WLE specimen, cavity shavings (if any) and the metastatic status of axillary (sentinel) lymph nodes as measured with the LightPath® Imaging System will be compared with histopathology results.
Positive margin on histopathology will be defined as:The participants will be followed up according to standard of care.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
19/LO/0500
Date of REC Opinion
17 Dec 2019
REC opinion
Further Information Favourable Opinion