A Novant Health breast surgeon led clinical trial research that supported the FDA approval of the only in vivo detection of residual breast cancer.

The research team at Novant Health Medical Park Hospital enrolled 103 patients in the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) Phase 3 trial, more than any other participating institution. Every single patient was referred by David Carr, MD, breast surgeon at Novant Health Breast Surgery, one of several specialized breast surgery clinics for Novant Health patients in Winston-Salem, Kernersville and Greensboro. Dr. Carr has been providing breast surgery exclusively for almost 20 years, focusing on benign and oncologic breast treatments with both surgical and nonsurgical options.

“My goal is to provide the most compassionate and comprehensive care and to help patients navigate their care,” Carr said. That includes referring them into clinical trials, a keyway he and other referring physicians can ensure patients stay on the leading edge of therapeutic development.

Thanks to research contributions by Carr’s team and other research site teams participating in the INSITE trial, there has been a major breakthrough in lumpectomy capabilities. In April 2024, the FDA approved Lumisight (pegulicianine), an imaging drug that allows physicians to determine – during an initial lumpectomy – whether any residual cancerous tissue remains after the primary tumor is removed. This is the first time the FDA has approved this level of imaging technology for use during a lumpectomy.

The Lumisight optical imaging agent is used in conjunction with the Lumicell Direct Visualization System. During the multicenter, randomized trial, surgeons worked with a hand-held imaging probe that fits inside the breast cavity. A cancer detection software was implemented to detect residual cancer in vivo. The residual cancer pinpointed by the Lumicell DVS measured 1-13 mm, including areas of low- and high-grade tumor. Of patients with positive margins, 14.5% of patients were able to be converted to final negative margins with the goal to avoid a second lumpectomy. In terms of safety, Lumisight was found to have a serious adverse event rate of 0.5%, which is comparable to other contrast agents.

Once it reaches the mainstream market, Lumisight can help ensure more patients not only leave surgery and focus on recovery, knowing they won’t need another lumpectomy, but also provide them peace of mind, knowing that all cancerous tissue has been removed.

Carr shares insights into his passion for breast surgery as well as his exciting contributions to clinical research with his team.

What motivated you to specialize in breast surgery?

My chair and co-chair at the University of Florida, where I completed my internship and residency in general surgery, actually wrote the book entitled The Breast: Comprehensive Management of Benign and Malignant Diseases. They were leaders in the field, so that’s when I was exposed to a lot of breast cancer care and developed my passion.

Was it an easy decision to start working on and enrolling patients in a clinical trial?

It was an easy decision. I was excited about the potential benefits to the patients. One of the more frustrating things as breast surgeons that we encounter is the occasional residual tumor that necessitates second lumpectomies. This technology dealt with trying to remove all of the cancer with the first lumpectomy to avoid subsequent surgeries. That inconveniences the patient and their families, it adds expense, and it continues the mental anxiety of the surgical encounter. Previously, there was no technology available that checked the lumpectomy cavity in vivo.

Why is clinical trial enrollment so beneficial?

My partners, Lori Kellam, MD, Jennifer Christman, MD, and I are committed to pursuing the most recent diagnostic technology and therapeutics in breast cancer treatment for our patients. Clinical trials are a way for them to access that early while contributing to therapeutic advancements. During this trial, it was exciting when patients realized that this technology helped them avoid a secondary surgery or detected satellite cancers around the lumpectomy cavity. It was exciting to have them see how it positively affected their care.

In addition to helping patients avoid a second lumpectomy, why will Lumisight be so valuable in practice?

The dream for it will be to use the technology in patients where it’s clinically appropriate. And there are potential future applications for the Lumicell technology in other cancers.