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NIH Funding Trial of Precise Tumor Removal System

Breast self exam

(National Cancer Institute)

9 August 2016. A company making a system to guide surgery that promises more complete removal of breast tumors received funding for a large-scale clinical trial testing the technology. National Cancer Institute, a part of National Institutes of Health, made the 2-year award to Lumicell Diagnostics Inc. of Wellesley, Massachusetts, with funding of about $1 million granted for the first year of the project.

Lumicell says its margin assessment system is designed to help completely remove tumors in breast tissue and other cancer sites that would otherwise be left behind. These resection margins are usually discovered after samples are analyzed in pathology labs, often several days after the first surgery, requiring another procedure. The company says some 30 percent of lumpectomy patients, or about 60,000 women in the U.S., face this situation, which adds emotional, cosmetic, and financial burdens.

Lumicell’s margin assessment system combines an optical imaging agent with a compact illumination device. The imaging agent, code-named LUM015, illuminates in the presence of characteristic enzymes from tumor cells, causing a fluorescence reaction in residual tumor cells. The hand-held device, code-named LUM 2.6, has software that detects and captures the fluorescence emissions in real-time to guide the surgery.

An early-stage clinical trial with 15 participants at Duke University testing the safety of LUM015 reported no adverse effects. Results of an intermediate-stage trial at Massachusetts General Hospital in Boston showed about 10 percent false positives by the system and no false negatives. A second part of the Mass. General study is evaluating the system when used with standard lumpectomy procedures.

In the new clinical trial, Lumicell plans to recruit 400 participants having lumpectomy surgery, with 300 individuals testing the system and 100 receiving the standard of care for comparison. Participants in the test group will receive the standard lumpectomy, plus imaging of the surgical cavity to identify any residual tumor tissue, followed by removal of the highlighted tissue guided by the system. The company says Stanford, Yale, Duke, and M.D. Anderson Cancer Center are joining Mass. General as test sites.

The award from National Cancer Institute is made under NIH’s Small Business Innovation Research or SBIR program. Lumicell says its technology can be applied to detect residual colorectal, esophageal, and pancreatic cancer after resection surgery. An early-stage clinical trial testing the system with those types of tumors is now recruiting participants.

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