Study of LGW16-03 To Identify Nerves

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.

NCT Number	NCT07385430
Lead Sponsor	Eric R. Henderson Collaborators: Oregon Health and Science University, National Institute of Neurological Disorders and Stroke (NINDS)
Conditions	Adults, Open-field Surgery, Major Nerve
Enrollment	38 participants
Start Date	2026-06-15
Primary Completion	2027-08-01 (estimated)
Study Completion	2027-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-01