LUM Imaging System to Detect Residual Cancer During Surgery to Start Advanced Clinical Trial

LUM Imaging System to Detect Residual Cancer During Surgery to Start Advanced Clinical Trial
A possibly pivotal clinical trial using an imaging technology – the LUM Imaging System by Lumicell — to detect residual tumor tissue in breast cancer patients undergoing surgery is in the planning stages, the company announced after the U.S. Food and Drug Administration (FDA) approved the system's use in a new study. The system uses a fluorescent contrast agent, called LUM015, that is activated by cancer and immune cells. Then, with a hand-held imaging device — LUM 2.6 — that fits into a lumpectomy site, doctors scan the cavity's walls for residual cancer cells. A proprietary decision software produces real-time images, guiding a surgeon in removing those cells. The new clinical trial, made possible by the Investigational Device Exemption (IDE) the FDA granted Lumicell, will build on findings from a Phase 2 feasibility study (NCT02438358) in about 60 women with breast cancer that is due to finish this month at Massachusetts General Hospital. Preliminary results, announced in a presentation at the 2016 American Society of Breast Cancer Surgeons Meeting, showed that the system was 100 percent effective at detecting residual cancer in the breast, including ductal carcinoma in-situ (DCIS), a pre-cancerous and non-invasive cancerous lesion of the breast, the company reported. Outcomes were confirmed by histopathology examination. Earlier research, including animal studies and a Phase 1 trial (NCT01626066) in about 15 patients, supported the LUM system being able to detect cancer in vivo in a mouse model of soft tissue sarcoma and ex vivo  in the patients. Results of the mice study were published in Science Translational Medicine in 2016. New data from the Phase 2 breast cancer study are expected in upcoming meetings. “We are excite
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