Lumicell is assessing its LUM Imaging System as a means to help surgeons better detect cancer cells that spread into the peritoneum — the membrane lining the abdominal cavity and covering the abdominal organs – during surgery, the company announced.
The clinical trial (NCT03834272) — which is recruiting participants at Massachusetts General Hospital in Boston — is for those with primary ovarian cancer, appendix cancer, gastrointestinal cancer, and mesothelioma whose cancer has spread into the peritoneum and are receiving their first surgery.
In one-third of cancer surgeries, surgeons fail to identify and remove the tumors completely, which may worsen a patient’s outcome significantly and require additional surgeries.
Lumicell is working to empower surgeons to better detect cancer cells, ensuring that all traces of the tumor are removed in a single surgery. The company uses a dye, called LUM015, that becomes fluorescent in the presence of cathepsins, which are a group of proteins largely produced by cancer cells.
This illuminates the cancer cells, enabling surgeons to see and remove cancer cells. The system comes with a handheld device to detect the illuminated cancer cells.
The LUM Imaging System has been tested with success during breast cancer surgery. In a study led by Barbara Smith, MD, PhD, director of the Breast Program at Massachusetts General Hospital, the imaging system effectively identified residual cancer cells that remained in the tumor cavity, allowing surgeons to remove these cancer cells without any adverse events.
Researchers now are assessing whether the LUM Imaging System also can be used in patients whose cancer has spread to the peritoneum, namely those with ovarian cancer, mesothelioma, appendix cancer, and gastrointestinal cancer.
The trial will include 18 participants in two phases. First, six patients will receive escalating doses of LUM015 — 1.0 mg and 1.5 mg per kilogram body weight — delivered into the blood before surgery. Then, the selected dose will be administered to 12 additional patients.
The trial’s main outcome is to assess tumor detection with LUM015 and compare it to conventional imaging methods. The number of patients experiencing an adverse event will be assessed as a secondary measure.
“This feasibility study is a critical first step in determining if the Lumicell System will be effective in improving quality of life for people with peritoneal metastases and ovarian cancer,” James Cusack, trial lead investigator, said in a press release.
“We will be evaluating the Lumicell System, by comparing the imaging results detected at the molecular level with the traditional microscopic evaluation, to improve surgical outcomes for patient with peritoneal surface malignancies,” he added.
“Our study found that the Lumicell Imaging System was effective for real time identification of residual cancer intraoperatively. This is an important advance as many breast cancer patients currently need second surgeries for positive margins,” Smith said. “We’re excited to determine whether this peritoneal feasibility study will bring the same advantages to treating patients with peritoneal metastases — with an ultimate goal to improve survival rates.”