A possibly pivotal clinical trial using an imaging technology – the LUM Imaging System by Lumicell — to detect residual tumor tissue in breast cancer patients undergoing surgery is in the planning stages, the company announced after the U.S. Food and Drug Administration (FDA) approved the system’s use in a new study.
The system uses a fluorescent contrast agent, called LUM015, that is activated by cancer and immune cells. Then, with a hand-held imaging device — LUM 2.6 — that fits into a lumpectomy site, doctors scan the cavity’s walls for residual cancer cells. A proprietary decision software produces real-time images, guiding a surgeon in removing those cells.
The new clinical trial, made possible by the Investigational Device Exemption (IDE) the FDA granted Lumicell, will build on findings from a Phase 2 feasibility study (NCT02438358) in about 60 women with breast cancer that is due to finish this month at Massachusetts General Hospital. Preliminary results, announced in a presentation at the 2016 American Society of Breast Cancer Surgeons Meeting, showed that the system was 100 percent effective at detecting residual cancer in the breast, including ductal carcinoma in-situ (DCIS), a pre-cancerous and non-invasive cancerous lesion of the breast, the company reported. Outcomes were confirmed by histopathology examination.
Earlier research, including animal studies and a Phase 1 trial (NCT01626066) in about 15 patients, supported the LUM system being able to detect cancer in vivo in a mouse model of soft tissue sarcoma and ex vivo in the patients. Results of the mice study were published in Science Translational Medicine in 2016.
New data from the Phase 2 breast cancer study are expected in upcoming meetings.
“We are excited to initiate these new studies with the LUM System, which we have designed to detect and illuminate tumor cells at the invasive front of the tumor micro-environment where macrophages and other immune cells interact with cancer cells,” Felix Geissler MD, PhD, chief medical officer of Lumicell, said in a press release. “By enabling surgeons to clearly see cancer cells in real time during surgery, we have the opportunity to avoid leaving cancer cells behind and reduce the need for repeat surgeries. We look forward to providing further clinical updates on our progress with the LUM System later this year.”
A first clinical trial in prostate cancer patients is also being planned under this IDE.
With these new trials, the LUM System in now being evaluated in clinical tests in people with five different solid tumors: breast, prostate, colorectal, esophageal, and pancreatic cancer. The study (NCT02584244) is currently recruiting about 20 patients with gastrointestinal cancers.
“We are moving our clinical program forward with strong momentum,” said Kelly Londy, chief executive officer of Lumicell. “We aim to set a new standard with our system in the field of image-guided cancer surgery, providing surgeons at any cancer facility with immediate visual feedback to detect tumor tissue beyond the margin of the specimen and opening up the potential to improve surgical outcomes for a broad range of cancer patients.”