Lightpoint Medical hopes to reduce the need for additional breast-conserving surgery with new
imaging system
Orange County, CA - February 28th 2017 - Lightpoint Medical, a medical device company founded in 2012, received European approval to launch their LightPath Imaging System back in 2015 and since then have completed their first-in-human clinical trial with promising results. With the ability to intraoperatively analyze removed tissue for signs of cancer, the LightPath Imaging System is the first approved system of its kind.
The system performance is based on Cherenkov luminescence imaging (CLI), molecular imaging used to detect cancer in real-time during surgery. This is done by looking for radiopharmaceuticals from Positron Emission Tomography (PET) contrast agents within the tissue. It features a 3-5 minute scan time, molecular specificity, 117 μm intrinsic resolution, and is compatible with all commercially-available PET imaging agents.
Currently the approximate number of patients who undergo breast-conserving surgery are 1 in 4. The procedure, also known as a lumpectomy, is a surgical procedure to remove cancer due to missing infected tissue in the initial sweep. Breast-conserving surgery is the primary treatment for those with early-stage breast cancer. The rates for multiple surgeries are so high due to surgeon inability to detect the cancer in the initial surgery with absolute certainty. The LightPath Imaging System aims to improve surgeon efficacy to reduce the need for several procedures.
The clinical trials using humans in the study, published in the Journal of Nuclear Medicine, was conducted by Guy's and St Thomas' Hospital in London, England. 22 patients diagnosed with an invasive breast cancer participated, and received 5 MBq/kg 18F-FDG 45 to 60 minutes prior to undergoing a sentinel lymph node biopsy. The surgery was performed using technetium-99m (99mTc) - nanocolloid activity of 150 MBq to aid in nodal detection against the gamma-probe background signal from the 18F-FDG.
The first 10 patients were used to optimize the imaging protocol while the remaining 12 patients were analyzed for the study. Ten of the 12 patients possessed elevated tumor radiance on CLI. The mean radiance was 560 ± 160 photons/s/cm2/sr while tumor-to background ratio was 2.41 ± 0.54. All patients had sentinel lymph nodes successfully detected and surgeons received a mean, and low, dose of 34 ± 15 μSv per procedure. These results indicate that intraoperative 18F-FDG CLI is an auspicious technique with minimal risk for intraoperative assessment of tumor margins in breast-conserving surgery.
“This clinical trial showed that molecular imaging agreed strongly with gold standard pathology and was straight-forward to interpret,” said Arnie Purushotham, the study’s principle investigator and professor at King's College London and Guy's Hospital. He went on further to say that although the technology is still in its early development, the team believes this method of intraoperative molecular imaging holds potential for improving the outcomes of breast cancer patients.To read their study click here.
