Breast cancer is the second most common type of cancer and cause of cancer death for women in the United States, affecting one in eight women overall.
Most women with breast cancer undergo lumpectomy surgery to remove the tumor and a rim of healthy tissue surrounding the tumor. After the procedure, the removed tissue is sent to a pathologist to look for signs of disease at the edge of the tissue assessed. Unfortunately, about 20 percent of women who have lumpectomies must undergo a second surgery to remove more tissue.
Now, an MIT spinout is giving surgeons a real-time view of cancerous tissue during surgery. Lumicell has developed a handheld device and an optical imaging agent that, when combined, allow surgeons to scan the tissue within the surgical cavity to visualize residual cancer cells. The surgeons see these images on a monitor that can guide them to remove additional tissue during the procedure.
In a clinical trial of 357 patients, Lumicell's technology not only reduced the need for second surgeries but also revealed tissue suspected to contain cancer cells that may have otherwise been missed by the standard of care lumpectomy.
The company received U.S. Food and Drug Administration approval for the technology earlier this year, marking a major milestone for Lumicell and the founders, who include MIT professors Linda Griffith and Moungi Bawendi along with PhD candidate W. David Lee '69, SM '70. Much of the early work developing and testing the system took place at the Koch Institute for Integrative Cancer Research at MIT, beginning in 2008.
The FDA approval also held deep personal significance for some of Lumicell's team members, including Griffith, a two-time breast cancer survivor, and Lee, whose wife's passing from the disease in 2003 changed the course of his life.
An interdisciplinary approach
Lee ran a technology consulting group for 25 years before his wife was diagnosed with breast cancer. Watching her battle the disease inspired him to develop technologies that could help cancer patients.
His neighbor at the time was Tyler Jacks, the founding director of the Koch Institute. Jacks invited Lee to a series of meetings at the Koch involving professors Robert Langer and Bawendi, and Lee eventually joined the Koch Institute as an integrative program officer in 2008, where he began exploring an approach for improving imaging in living organisms with single-cell resolution using charge-coupled device (CCD) cameras.
"CCD pixels at the time were each 2 or 3 microns and spaced 2 or 3 microns," Lee explains. "So the idea was very simple: to stabilize a camera on a tissue so it would move with the breathing of the animal, so the pixels would essentially line up with the cells without any fancy magnification."
That work led Lee to begin meeting regularly with a multidisciplinary group including Lumicell co-founders Bawendi, currently the Lester Wolfe Professor of Chemistry at MIT and winner of the 2023 Nobel Prize in Chemistry ; Griffith, the School of Engineering Professor of Teaching Innovation in MIT's Department of Biological Engineering and an extramural faculty member at the Koch Institute; Ralph Weissleder, a professor at Harvard Medical School; and David Kirsch, formerly a postdoc at the Koch Institute and now a scientist at the Princess Margaret Cancer Center.
"On Friday afternoons, we'd get together, and Moungi would teach us some chemistry, Lee would teach us some engineering, and David Kirsch would teach some biology," Griffith recalls.
Through those meetings, the researchers began to explore the effectiveness of combining Lee's imaging approach with engineered proteins that would light up where the immune system meets the edge of tumors, for use during surgery. To begin testing the idea, the group received funding from the Koch Institute Frontier Research Program via the Kathy and Curt Marble Cancer Research Fund.
"Without that support, this never would have happened," Lee says. "When I was learning biology at MIT as an undergrad, genetics weren't even in the textbooks yet. But the Koch Institute provided education, funding, and most importantly, connections to faculty, who were willing to teach me biology."
In 2010, Griffith was diagnosed with breast cancer.
"Going through that personal experience, I understood the impact that we could have," Griffith says. "I had a very unusual situation and a bad kind of tumor. The whole thing was nerve-wracking, but one of the most nerve-wracking times was waiting to find out if my tumor margins were clear after surgery. I experienced that uncertainty and dread as a patient, so I became hugely sensitized to our mission."
The approach Lumicell's founders eventually settled on begins two to six hours before surgery, when patients receive the optical imaging agent through an IV. Then, during surgery, surgeons use Lumicell's handheld imaging device to scan the walls of the breast cavity. Lumicell's cancer detection software shows spots that highlight regions suspected to contain residual cancer on the computer monitor, which the surgeon can then remove. The process adds less than 7 minutes on average to the procedure.
"The technology we developed allows the surgeon to scan the actual cavity, whereas pathology only looks at the lump removed, and [pathologists] make their assessment based on looking at about 1 or 2 percent of the surface area," Lee says. "Not only are we detecting cancer that was left behind to potentially eliminate second surgeries, we are also, very importantly, finding cancer in some patients that wouldn't be found in pathology and may not generate a second surgery."
Exploring other cancer types
Lumicell is currently exploring if its imaging agent is activated in other tumor types, including prostate, sarcoma, esophageal, gastric, and more.
Lee ran Lumicell between 2008 and 2020. After stepping down as CEO, he decided to return to MIT to get his PhD in neuroscience, a full 50 years since he earned his master's. Shortly thereafter, Howard Hechler took over as Lumicell's president and chief operating officer.
Looking back, Griffith credits MIT's culture of learning for the formation of Lumicell.
"People like David [Lee] and Moungi care about solving problems," Griffith says. "They're technically brilliant, but they also love learning from other people, and that's what makes makes MIT special. People are confident about what they know, but they are also comfortable in that they don't know everything, which drives great collaboration. We work together so that the whole is bigger than the sum of the parts."