Patient Engagement, Hospitals

Lumicell aims to reduce repeat surgeries in breast cancer

Lumicell’s technology makes cancer cell at the margins of healthy tissue light up providing real time information during surgery of whether all the suspect tissue is being removed in one go.

Close-up view of a cancer cell

Close-up view of a cancer cell

One of the myriad problems with cancer surgery, particularly breast cancer surgery, is what is known as cancer at the margins. The problem that women who undergo such procedures often have to come for repeat procedures to get all of the suspect tissue out.

One company hoping to reduce the incidence of repeat procedures is Wellesley, Massachusetts-based Lumicell. The company just secured a grant worth about $2 million from the National Cancer Institute to conduct a pivotal trial to test its breast cancer removal sugical device.

If successful, the device can prevent repeat operations, potentially saving the healthcare system nearly $1 billion annually, according to a statement from Lumicell.

The cash infusion will fund the 400-person pivotal trial of the Lumicell Margin Assessment System, to be conducted at several healthcare institutions including Massachusetts General Hospital Cancer Center, The University of Texas MD Anderson Cancer Center and Stanford Cancer Institute. The trial is expected to begin in the second half of 2017.

More than 60,000 women require a re-excision due to incomplete removal of the cancerous tissue, according to Lumicell. According to the trial’s principal investigator, breast surgical oncologist Dr. Barbara Smith of Massachusetts General Hospital, the re-operation rate is estimated be as high 40%.

“After the tissue is removed, if there are any cancer cells are at the edge of the incision, or in the jargon we use, at the margin, then we have to do another surgery,” Smith said in a phone interview.

Sponsored Post

Physician Targeting Using Real-time Data: How PurpleLab’s Alerts Can Help

By leveraging real-time data that offers unprecedented insights into physician behavior and patient outcomes, companies can gain a competitive advantage with prescribers. PurpleLab®, a healthcare analytics platform with one of the largest medical and pharmaceutical claims databases in the United States, recently announced the launch of Alerts which translates complex information into actionable insights, empowering companies to identify the right physicians to target, determine the most effective marketing strategies and ultimately improve patient care.

Cancer often grows in an irregular shape, she explained. Sometimes there are invisible strands of cancerous tissue extending from the main tumor.

“We’re trying to find microscopic disease with our eye and we just can’t do it,” she said.

Following a lumpectomy, pathologists test the excised tissue to check for positive (or cancerous) margins, but women have to wait a week for the results. Another treatment option is whole breast removal, or mastectomy, but many women prefer to keep their breasts. Smith said lumpectomies are as effective as mastectomies as long as specific rules are followed.

Removing all of the cancerous tissue is certainly one of those rules, and doing so in a single surgical procedure is highly preferable. That requires removing some healthy tissue at the margin of the cancerous tumor.

The Margin Assessment System is supposed to provide real-time feedback so that all of the cancer is removed during the initial surgery. It is designed to minimize interference with the normal surgical workflow.

“You don’t want to make an operation take a lot longer to finish,” said Smith, the principal investigator of the device’s 65-person feasibility study, that is ongoing.

In the first step, a fluorescent dye is intravenously administered into the patient prior to the surgery. Following the initial excision of the tumor, the surgeon illuminates the resulting cavity using a handheld probe containing software for single-cell detection. Due to the dye, any remaining cancer instantly lights upon exposure to the illumination and appears on an external monitor, Smith said. The residual cancerous tissue can then be removed immediately.

The feasibility study had no adverse events while detecting residual cancer at a rate of 100%. During the upcoming pivotal trial, the endpoint will be a comparison of the positive (or cancerous) margin rate between surgeries that deploy the Margin Assessment System and those that don’t. The potential for the Margin Assessment System to reduce the size of excision will also be studied, Smith said, because that would have a cosmetic benefit.

Lumicell is aiming to offer an improvement over the FDA-approved MarginProbe System, made by Dune Medical. That device provides a method for reducing the positive margin rate and cutting down on re-excisions similar to Lumicell’s Margin Assessment System.

One crucial difference is that the MarginProbe System analyzes the breast cancer tumor once it has been removed from body. The device’s probe uses a sensor to assess the edges of the excised tissue. A positive reading of a section of the tissue leads to additional shaving of the corresponding location in the excision’s cavity.

In other words, if the MarginProbe finds that the edge of the excised tissue is cancerous, physicians must then determine where the edge was located when it was part of the breast (analogous to trying to determine where a puzzle piece fits inside a puzzle) so that they can excise additional tissue in the same area. Smith said the task can be challenging because the excised tissue sometimes loses its shape when it is removed from the body.

“Based on the early studies that were done, it didn’t seem like the MarginProbe changed the positive margin rate that much,” Smith said.

However, a 2014 study posted on the MarginProbe website found that use of the device resulted in a re-excision (or positive margin) rate of 9.7%, compared to a historical rate of 25.8% when the device was not used.

Smith said she does not have any financial connections to Lumicell. The company’s Margin Assessment System is also in early-stage studies for the detection of colorectal and pancreatic cancer, as well as a condition known as Barret’s Esophagus, according to the company website.

The technology is an example of the advance of intraoperative imaging, or the use of medical imaging in real-time, so that the visual information can be used during the actual surgery, hopefully resulting in better outcomes, such as fewer repeat procedures.

Photo credit: Getty Images, Ilexx 

CORRECTION: A previous version of the story mistakenly said that the 65-person feasibility study concluded in April. The first part had concluded but the trial has been expanded and is ongoing.