FDA Approves Trial for Intraoperative Image-Guided Cancer Surgery System

The US Food and Drug Administration (FDA) has provided Investigational Device Exemption (IDE) approval for company to trial a new image-guided cancer surgery system for intraoperative imaging of breast cancer.

The surgical system consists of a cancer-specific molecular imaging agent, and a lightweight hand-held single-cell detection imaging device, and is intended for use within existing workflow of the breast cancer surgeries.

The system was developed by Lumicell (Wellesley, MA, USA), and the trial will be carried out at the Massachusetts General Hospital (MGH; Boston, MA, USA). The trial is being funded by the US National Cancer Institute (NCI) as part of the NCI Experimental Therapeutics (NExT) program.

The Lumicell surgical system addresses the need to remove all cancer cells in the tumor bed, during the first surgery. The intraoperative detection system enables surgeons to find and remove residual cancer cells, in real-time, in the tumor bed.

W. David Lee, CEO of Lumicell, said, “Launching a feasibility study for intraoperative imaging of breast cancer during surgery is a critical next step for Lumicell. The NCI grant allows our team to demonstrate the efficacy of our system in reducing rates of positive margins and repeat surgeries. By enabling surgeons to remove sub-millimeter residual cancer, we expect to improve patient outcomes.”

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