Breast cancer surgery, particularly lumpectomy, often requires precise removal of cancerous tissue to ensure complete eradication. Unfortunately, traditional surgical tools sometimes miss residual cancer, leading to the need for additional surgeries. However, in an article by Cancer Health, a new development has been highlighted that could enhance the accuracy of breast cancer surgery and reduce the likelihood of repeat operations.

In April, the U.S. Food and Drug Administration (FDA) approved a new imaging system called the LumiSystem. This system, developed at the Duke University lab of David G. Kirsch, MD, PhD. Kirsch, combines advanced imaging technology with a novel fluorescent imaging agent. The LumiSystem allows surgeons to scan the breast cavity during surgery, identifying any remaining cancerous tissue that might have been missed otherwise.

The LumiSystem originated from research funded by the Damon Runyon-Rachleff Innovation award. This award supports innovative and high-impact cancer research. Dr Kirsch’s team designed and tested the prototype imaging device and fluorescent imaging agents in mice before moving to clinical trials with human patients. The transition from animal models to human trials was expedited by preliminary trials in canine cancer patients at Duke University.

The U.S. FDA stated in an article that new technology was tested in a multicenter, intra-patient controlled clinical trial involving 357 breast cancer patients undergoing lumpectomy. The trial’s results, as highlighted by the FDA, were promising. Approximately 7.6% of patients had residual cancer detected and removed using the LumiSystem. The system demonstrated an image-level sensitivity of 49.1% and specificity of 86.5%. While 43% of patients experienced at least one false positive image, and 8% had at least one false negative image, the overall potential of this technology to reduce the need for second surgeries is significant.

The imaging drug Lumisight (pegulicianine) is described as a key component of the LumiSystem. Administered via intravenous injection before surgery, Lumisight is used with the Lumicell Direct Visualization System (DVS) to assist in the intraoperative detection of cancerous tissue. The FDA approval of Lumisight is a major milestone, as it represents the first imaging drug specifically approved for use during breast lumpectomy surgery.

Safety considerations for Lumisight include the risk of hypersensitivity reactions, including anaphylaxis. The FDA has included a boxed warning in the prescribing information, recommending that all patients be assessed for hypersensitivity to contrast media or polyethylene glycol (PEG) products before administration. Additionally, all patients should be monitored for hypersensitivity reactions following Lumisight administration.

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