Lumicell to Initiate Breast Cancer Surgical Imaging Study
Lumicell has won FDA investigational device exemption approval to initiate a feasibility study of its LUM015 surgical imaging system for breast cancer, the Wellesley, Mass., devicemaker announced Wednesday. The trial will be funded by a National Cancer Institute grant.
The imaging system aids medical professionals in efforts to remove residual cancer cells within the tumor bed during the first surgery, eliminating repeat surgeries caused by positive margins or local recurrence, the devicemaker claims.
LUM015 is a hand-held single-cell detection imaging device and a cancer-specific molecular imaging agent. The company recently completed a Phase I safety study evaluating the system, with no agent-related adverse events found.
Lumicell hopes to expand the LUM015’s indications to include lung, prostate, ovarian, colorectal and brain cancer surgical imaging. — Jason Scott