Lumicell Kicks Off Pilot Study of its Technology for Gastrointestinal Cancers

Lumicell Inc. received approval from the U.S. Food and Drug Administration to launch a feasibility study in gastrointestinal cancers.

The study will focus on imaging tissue in patients with esophageal, colorectal and pancreatic cancers. It will be conducted at Massachusetts General Hospital (MGH) and will be led by Charles S. Fuchs, M.D., director of the Gastrointestinal Cancer Center at Dana-Farber Cancer Institute and Andrew T. Chan, M.D., program director of gastroenterology training at MGH.

The National Cancer Institute’s (NCI) SPORE Program—the Specialized Programs of Research Excellence—is funding the pilot study through the NCI Translational Research Program (TRP). TRP is home of the SPOREs, a cornerstone of NCI’s efforts to promote collaborative, interdisciplinary translational cancer research.

SPORE grants involve both basic and clinical/applied scientists and support projects that will result in new and diverse approaches to the prevention, early detection, diagnosis and treatment of human cancers. SPOREs in GI cancers focus on translational research in the gastrointestinal system, which includes cancers of the colon, rectum, stomach, esophagus, small intestine, liver, gallbladder and other digestive organs.

“The launch of a feasibility study in gastrointestinal cancers is an important next step for our company,” said W. David Lee, CEO of Wellesley, Mass.-based Lumicell. “We are proud to partner with the Dana-Farber Cancer Institute and MGH to conduct this study. The SPORE grant will allow our team to test our imaging system in patients with esophageal, colorectal and pancreatic cancers. We will seek to demonstrate that our technology detects cancer as confirmed by pathology.”

According to the American Cancer Society, more than 290,200 newly diagnosed cases of cancer in the digestive system, and 144,570 deaths, were expected in the United States in the year 2013. Colorectal cancer is the third-leading cause of cancer death and was expected to cause 50,830 deaths in the United States in 2013.

“NCI and the SPORE Program are both leaders in cancer research and their support of this study in gastrointestinal cancers is a critical step in moving this technology forward,” said Fuchs. “Our study includes three surgical oncologists from both Dana Farber/Brigham and Women’s Cancer Center and MGH. I truly look forward to working with this team toward the goal of demonstrating the effectiveness of this surgical system.”

Lumicell is addressing a primary challenge in cancer surgery—the need to remove all cancer cells within the tumor bed during the first surgery. In the field of cancer surgery, the goal is clean margins. Lumicell’s intraoperative detection system is designed to provide surgeons with the tools to perform a thorough removal of any residual cancer cells in real-time within the tumor bed thus eliminating the need for repeat surgeries due to positive margins or local recurrence.

Lumicell’s surgical system combines a lightweight hand-held single-cell detection imaging device and a cancer-specific molecular imaging agent. This image-guided technology is designed to fit within the existing surgical workflow. The company’s devices and imaging agents are optimized for the specific cancer-type and surgical procedure.

Lumicell is initially investigating its imaging system in patients undergoing surgery for breast cancer and sarcomas. Additional future indications will include surgeries for lung, prostate, ovarian, colorectal and brain cancers.