MedTrace Logo

Study of LGW16-03 To Identify Nerves

NCT07385430 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-06-01

No results posted yet for this study

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.

Conditions

  • Adults
  • Open-field Surgery
  • Major Nerve

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.

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Eric R. Henderson

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2027-08-01
Completion
2027-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07385430 on ClinicalTrials.gov