During cancer surgery, surgeons depended on pathologists to tell them if resected cancerous tissue has clear margins. This means that the tissue surrounding the tumor contains no cancer cells, and that all cancer cells have most likely been removed by surgery.
In some surgeries, cancer tumors are intertwined with vital tissues. In these situations, the surgeon wants to remove the minimum amount of tissue possible while simultaneously getting clear tumor margins. The goal is to remove all the cancer so that a repeat surgery is not necessary.
According to most pathologists, the process of using tissue biopsy to determine clear surgical margins is not 100% accurate in predicting surgical outcomes. One estimate is that as many as 30% of patients will need repeat surgeries for cancerous cells which were left behind after surgery.
Eliminating the need for repeat surgeries
One company, Lumicell, has developed a technology which can identify residual cancer cells during a patient’s initial surgery. In this case, all cancer cells can be removed, eliminating the need for a second surgery to remove cancer cells left behind. This technology has the potential to significantly improve surgical outcomes and reduce health care costs by eliminating the need for repeat surgeries.
After a patient’s tumor is removed, surgeons using Lumicell’s handheld imaging device can scan the empty cavity to look for any remaining cancer cells. The company’s fluorescent optical contrast agent will fluoresce or illuminate any cancerous cells left behind. Additionally, Lumicell’s decision-support software displays an image to help guide surgeons to any cancerous tissue. The Lumicell System includes three components: the imaging agent, the handheld device, and the decision-support software.
Kelly Londy, Lumicell CEO, explained that the imaging agent is designed to activate in the presence of specific proteases: enzymes that break down proteins. Cancer cells secrete more of these than healthy cells, allowing them to be identified and targeted.
The company’s lead product, the Lumicell System, is in late-stage development for breast cancer surgery. It features an investigational optical agent and a handheld device that enables cancer surgeons to see and remove cancer cells in real-time during surgery. The Lumicell System was designed and developed by MIT engineers in partnership with leading breast cancer surgeons to fit seamlessly within the existing surgical workflow.
The Lumicell System is also under investigation for colorectal cancer, Barrett’s esophagus, and brain metastases. Lumicell is pursuing the combination product pathway for its technology with the FDA and expects to file a premarket approval application by the beginning of 2019.
Medical Design & Outsourcing, Sarah Faulkner, March 27, 2018.
Lumicell’s website: http://www.lumicell.com