Clinical Trials in Multiple Solid Tumor Indications
The investigational Lumicell Direct Visualization System (DVS)* has potential utility in multiple solid tumor indications.
Results from Completed Clinical Trials
- Phase 1 safety study at Duke University Medical Center in breast cancer and sarcoma was published in Science Translational Medicine (January 2016)
- Single-site feasibility study at Massachusetts General Hospital was published in the following publications:
Prostate cancer (ex vivo)
- Feasibility study to detect prostate cancer in resected tissue; next steps include an in vivo study (NCT03441464)
National Cancer Institute (NCI) Awarded Lumicell with a Small Business Innovation Research Grant (SBIR) to partially fund
- Multi-center feasibility study in breast cancer, which completed enrollment in late 2019 and included 234 patients newly diagnosed with ductal cancer in situ undergoing breast conserving surgery at 16 U.S. sites
- Lumicell’s pivotal INSITE (Investigation of Novel Surgical Imaging for Tumor Excision) Breast Cancer clinical trial (NCT03686215), which completed enrollment in late 2021, with 406 adult patients enrolled across 14 sites. Results of the INSITE trial are under peer review and will be included in Lumicell’s Premarket Approval and New Drug Application submissions to the U.S. Food & Drug Administration
Ongoing Clinical Trials:
NCI Awarded Breast Cancer Principal Investigator at Massachusetts General Hospital with an RO1 grant to fund:
- Feasibility study (NCT04440982), which was initiated in fall 2020 to evaluate for the first-time use of the Lumicell DVS in breast cancer patients undergoing neoadjuvant therapy
Gastrointestinal cancers (ex vivo)
- Supported by a Stand Up to Cancer (SU2C) grant awarded to the GI Principal Investigator, the feasibility of the Lumicell DVS is being evaluated in patients to detect esophageal, gastric, pancreatic, and colorectal cancers (NCT02584244)
Peritoneal metastases (in vivo)
- This study explores the feasibility of the Lumicell DVS to detect peritoneal surface malignancies, including peritoneal metastases from primary ovarian and colon cancer, as well as mesothelioma (NCT03834272)
Brain cancer (in vivo)
- This study explores the feasibility of the Lumicell DVS to detect brain cancers that include glioblastomas, low grade gliomas and metastases to the brain (NCT03717142)
For detailed information on Lumicell’s clinical trials, visit ClinicalTrials.Gov.
*CAUTION: LUMISIGHT and Lumicell Direct Visualization System (DVS) are investigational products that are limited by Federal (or United States) law to investigational use. LUMISIGHT and Lumicell DVS are not authorized for marketing for any indication in any jurisdiction.