Lumicell, a leader in the field of image-guided cancer surgery, announced it successfully completed its Phase 2Ia feasibility study on the Company’s groundbreaking LUM Imaging System, consisting of an optical contrast agent, LUM015, and the LUM Imaging Device.
Collaborators from the Breast Program at Massachusetts General Hospital will present a poster based on the clinical study titled "Feasibility of the LUM imaging system for real-time, intraoperative detection of residual breast cancer in lumpectomy cavity margins."
Lumicell is addressing the number one challenge in breast cancer surgery – the need to remove all cancer cells within the lumpectomy cavity during the first surgery. In the field of cancer surgery, the goal is clean margins.
Obtaining tumor-free margins is crucial for local control in breast conserving surgery. Every year more than 60,000 women undergoing lumpectomy must endure re-excision due to positive margins discovered on final histopathology examination.
Second surgeries increase discomfort, add emotional and cosmetic expenses to the patient, and may cost the healthcare system close to $1B annually.
The LUM Imaging System could be used for intraoperative, in vivo detection of microscopic residual cancer in the lumpectomy cavity to achieve tumor-free margins at the time of surgery, thus reducing rates of re-excision. The Company’s feasibility study is the first to use the LUM Imaging System in vivo in human cancers.
"Obtaining tumor-free margins is critical in breast conserving surgeries," said Barbara L. Smith, MD, PhD, Director of the Breast Program at Massachusetts General Hospital, who led the study.
"We are encouraged by our initial findings demonstrating the potential of the LUM Imaging System for real-time identification of residual cancer cells in the lumpectomy cavity of patients with breast cancer."
Research from a prior study, recently published in Science Translational Medicine, highlights the use of LUM015 to detect cancer in vivo in a mouse model of soft tissue sarcoma (STS) and ex vivo in a first-in-human Phase 1 clinical trial (NCT01626066).
This Phase 2a feasibility study (NCT02438358) in breast cancer patients demonstrates the first-ever use of the LUM Imaging System for in vivo imaging in breast conserving surgeries.
The study results show that the LUM Imaging System differentiates between tumor and normal tissue in vivo and ex vivo with administration of LUM015 just a few hours before the surgery with no impact to pre-operative and surgical workflow.
Most importantly, it displayed 100% detection of residual cancer. Based on these results, the feasibility study is being expanded into a larger cohort of breast cancer patients in which the LUM Imaging System will be used in vivo to guide the resection of tumor and evaluate the reduction in positive margins and re-excisions.
"We aim to help surgeons increase the chances of success in the first surgery by giving real-time visual feedback of residual cancer in the tumor cavity," said W. David Lee, CEO of Lumicell.
"A diagnosis of breast cancer can be devastating, and increasing the chances of success with the first surgery can be tremendously reassuring to patients and their families. We are proud to partner with Massachusetts General Hospital and the National Cancer Institute and are encouraged by our first-in-human study results."
Pre-clinical toxicology studies and clinical production of LUM015 was financed with federal funds from the National Cancer Institute, National Institutes of Health, under NCI’s Experimental Therapeutics Program.
Part of this clinical trial is conducted with federal funds from the National Cancer Institute, National Institutes of Health, Grant R21 CA173762.