With this pivotal trial, the system gets an important step closer to FDA approval, but more importantly, patients and physicians are one step closer to having an innovative technology available for care.
NEWTON, Mass. (PRWEB) November 05, 2019
Lumicell, Inc., an innovation leader in image guided cancer surgery, today announced it has begun its pivotal trial of the Lumicell Imaging System for breast cancer — a major milestone on its path toward FDA submission for approval. The two-arm, randomized pivotal study follows completion of our feasibility clinical study of 234 patients at 16 sites. In the pivotal study, the technology will be used on 170 patients at up to 20 large academic centers and community breast cancer centers for intraoperative detection and removal of residual cancer in breast conserving surgery.
“This is an exciting moment for breast cancer patients and their physicians. Since the very beginning, I’ve been encouraged by the results generated using the Lumicell System,” said Barbara Smith, MD, PhD, lead investigator of the Lumicell breast cancer trials. Dr. Smith, Director of the Breast Program at Massachusetts General Hospital and Professor of Surgery at Harvard Medical School, also shared, “with this pivotal trial, the system gets an important step closer to FDA approval, but more importantly, patients and physicians are one step closer to having an innovative technology available for care.”
Breast-conserving surgery is a critical first step in the treatment for many women with breast cancer with the goal of removing all cancer cells while minimizing the removal of healthy tissue. However, today, surgeons do not have adequate tools to determine in real-time if all the cancer has been removed during the initial surgery; instead, patients must wait multiple days after surgery to find out if all the cancer has been completely removed. Unfortunately, for 1 in 4 breast cancer patients, cancer cells are found at the margins of the removed tissue, suggesting cancer cells may remain in the cavity, typically requiring patients to undergo a second surgery to remove the remaining cancer.
The Lumicell System was developed to enable surgeons to see and remove residual cancer in real-time, in vivo, during the initial surgery — with the goal of reducing the risk of second surgeries and cancer recurrence. The system is designed to minimize healthy tissue removal while integrating easily into the surgical workflow.
“We are very excited to move into the pivotal trial stage for the Lumicell System,” said Andrey Zarur, PhD, Executive Chairman at Lumicell. “We believe we have developed a trial design which will be compelling to patients and surgeons, demonstrate the clinical benefit of using the system in the treatment of breast cancer and generate data to submit for FDA approval.”
The Lumicell System is potentially useful for surgical guidance in the removal of numerous other cancer types, and it is currently being tested in feasibility trials for treatment of prostate, brain, colorectal, esophageal and pancreatic cancers, as well as peritoneal metastases from primary ovarian and colon cancers.
For more information about Lumicell’s clinical trials, visit http://www.lumicell.com/clinical-trials/clinical-trials.php.
About Lumicell, Inc.
Lumicell is a technology leader in the field of image-guided cancer surgery. The company is developing a novel system that enables real-time detection of tumor tissue in patients so that no cancer cells are left behind during surgery. The company’s Lumicell System has unprecedented ability to see and guide removal of cancer cells remaining in the surgical cavity – beyond the margin of the specimen – and has the potential to significantly improve surgical outcomes and reduce healthcare costs by eliminating the need for repeat surgeries. Lumicell is investigating the Lumicell System in patients undergoing surgery for breast cancer, ovarian cancer, prostate cancer, brain cancer, colorectal, esophageal and pancreatic cancers. Additional future indications are planned to include perfusion, wound care and infection, and surgeries for lung, and liver cancers. For more information, please visit http://www.lumicell.com.