Originally designed by engineers and scientists from MIT in partnership with leading breast cancer surgeons, and then further developed at Lumicell, the Lumicell DVS aims to seamlessly integrate into the existing surgical workflow, using a handheld probe that is placed inside the breast cavity.
Despite the emergence of new surgical approaches, there remains a significant unmet need for surgeons and patients of real-time detection of residual cancer.
The investigational optical imaging agent, LUMISIGHT, contains a fluorescent dye that is optically inactive when injected into the patient. It is designed to be activated by enzymatic activity in and around the tumor. LUMISIGHT leverages the body’s host immune response common to all solid tumors, rather than targeting specific receptors of a particular type of cancer.
The Lumicell DVS has potential utility for development in multiple solid tumor indications.
Over 800 patients have been clinically evaluated in 7 different cancer types across 18 leading medical centers in the United States.
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May 2022
Lumicell’s pivotal INSITE (Investigation of Novel Surgical Imaging for Tumor Excision) Breast Cancer clinical trial (NCT03686215). Results of the INSITE trial are published in NEJM Evidence and have been included in Lumicell’s Premarket Approval and New Drug Application submissions to the U.S. Food & Drug Administration
April 2020
Phase C multi-center feasibility study in breast cancer
October 2017
Single-site feasibility study
Massachusetts General Hospital
January 2016
Phase 1 safety study in breast cancer and sarcoma
Duke University Medical Center
February 2021
Feasibility study to detect prostate cancer in resected tissue; next steps include an in vivo study (NCT03441464)
Initiated September 2020
Feasibility study (NCT04440982), to evaluate for the first-time use of the Lumicell DVS in breast cancer patients undergoing neoadjuvant therapy
Initiated August 2016
Feasibility study of the Lumicell DVS to detect GI cancers including gastric, colorectal, pancreatic, and esophageal cancers (NCT03834272)
Initiated March 2019
Feasibility study of the Lumicell DVS to detect peritoneal surface malignancies, including peritoneal metastases from primary ovarian and colon cancer, as well as mesothelioma (NCT03834272)
Initiated May 2019
Feasibility study 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.
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