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NOT YET RECRUITING
NCT07385430
PHASE1

Study of LGW16-03 To Identify Nerves

Sponsor: Eric R. Henderson

View on ClinicalTrials.gov

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

Interventions

DRUG

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