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Study of LGW16-03 To Identify Nerves
Sponsor: Eric R. Henderson
Summary
The primary goal of this study is to determine the safety and tolerability of LGW16-03, a novel nerve-labeling fluorophore, in participants undergoing open-field orthopaedic surgery. Secondary goals include: 1) identifying the lowest dose without adverse events that provides peak florescence imaging contrast, and 2) characterizing the pharmacokinetics of LGW16-03. Participants will receive a one-time intravenous infusion of the investigational drug (LGW16-03) prior to their planned surgery. Participants' vitals will be closely monitored and will have blood samples taken at regular intervals. Fluorescence images of their major nerve will be taken during surgery. Participants will have one study follow-up visit approximately 30 days after their surgery.
Official title: Phase 1 Study of LGW16-03 To Identify Nerves
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
38
Start Date
2026-05-01
Completion Date
2027-08-01
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
LGW16-03
LGW16-03 is a non-biological medical imaging agent classified as a contrast agent, consistent with FDA definitions. It is intended to improve intraoperative visualization of specific tissues-namely, peripheral nerves-by enhancing the relative difference in fluorescence signal intensity between nerve and adjacent tissues.
Locations (1)
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States