BREAKING NEWS: We are pleased to announce FDA approval of LUMISIGHT™ (pegulicianine) and Lumicell™ DVS. To the hundreds of women and dedicated investigators who participated in this important clinical work that brought us to where we are today, THANK YOU! We wouldn’t be here without your support.
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The Science Propelling Lumicell

Clinical Trials in Multiple Solid Tumor Indications

LUMISIGHT™ is a prodrug that is designed to be optically inactive when intact and produces a fluorescent signal after its peptide chain is cleaved by cathepsins and matrix metalloproteases (MMPs). The levels of these enzymes are higher in and around tumor and tumor-associated cells than in normal cells.

The Lumicell™ Direct Visualization System (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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FDA Approval
Peritoneal Metastases
GI Cancers

Awarded Breakthrough Device Designation for the Lumicell DVS in breast, GI and all solid tumors. Awarded Fast Track Designation for the LUMISIGHT Optical Imaging Agent for breast cancer.

"I am passionate about helping improve cancer outcomes."

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Completed Clinical Trials

Breast Cancer

February 2024

Feasibility study (NCT04440982), to evaluate for the first-time use of the Lumicell DVS in breast cancer patients undergoing neoadjuvant therapy

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

Multi-Center feasibility study in breast cancer

October 2017

Single-site feasibility study. Massachusetts General Hospital – Source

  • Initial Cohort Publication: Breast Cancer Research and Treatment – Source
  • Second Cohort Publication: Annals of Surgical Oncology – Source
  • Overall Performance Publication: Breast Cancer Research and Treatment – Source

January 2016

Phase 1 safety study in breast cancer and sarcoma

Duke University Medical Center

Science Translational Medicine 

Prostate Cancer (ex vivo)

February 2021

Feasibility study to detect prostate cancer in resected tissue; next steps include an in vivo study (NCT03441464)

Ongoing Clinical Trials

Gastrointestinal Cancer (ex vivo)

Initiated August 2016

Feasibility study of the Lumicell DVS to detect GI cancers including gastric, colorectal, pancreatic, and esophageal cancers (NCT03834272)

Peritoneal Metastases (in vivo)

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)

Brain Cancer (in vivo)

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