Study of LGW16-03 To Identify Nerves

NCT07385430 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 02003082
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Open-field Surgery; Adults; Major Nerve

Keywords

Surgery; Nerve; Fluorescence imaging

Outcome Measures

Primary Outcomes (1)

• Assess safety and tolerability of LGW16-03

  This study's primary outcome is safety, which will be evaluated by the occurrence of treatment-related adverse events, with attention to frequency and severity as determined by CTCAE v5.0.

  Immediately after infusion of the drug until the post-operative follow-up appointment which will occur approximately 30 days after surgery.

Secondary Outcomes (2)

• Assess dose of LGW16-03

  Immediately after infusion of the drug until the post-operative follow-up appointment which will occur approximately 30 days after surgery.

• Assess time of peak LGW16-03 concentration

  Regular blood draws will occur from infusion to 24 hours post-infusion.

Other Outcomes (7)

• Evaluate the ability of LGW16-03 to generate detectable fluorescence signal in exposed nerve tissue during surgery.

  From when major nerve is first visible during surgery, approximately every 30 minutes until surgery ends.

• Assess operating surgeon-reported experience in identifying nerve tissue with LGW16-03

  Operating surgeon experience will be evaluated immediately following surgery.

• Assess operating surgeon-reported experience in identifying nerve tissue with LGW16-03

  Operating surgeon experience will be evaluated immediately following surgery.

Study Arms (1)

LGW16-03

EXPERIMENTAL

Participants will receive a single IV infusion of the investigational drug (LGW16-03).

Drug: LGW16-03

Interventions

LGW16-03 DRUG

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.

LGW16-03

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled and medically cleared for a standard of care, open-field (not endoscopic) surgical procedure wherein a major nerve will be exposed and visible to the imaging equipment.
• Participants must be willing and able to provide informed consent for participation in the study and adhere to all study procedures.
• Intact motor and sensory function in the nerve to be imaged, as determined by physical exam performed by the operating surgeon or clinician on the study team, including:
• /5 motor strength in relevant muscle groups.
• Normal sensation on testing with a 5.07 Semmes-Weinstein filament or other valid testing method.
• No documented history of neuropathy of any kind.
• Age ≥ 18 years old.
• Medical clearance for surgery provided by a supervising medical provider (surgeon or primary care provider).
• Adequate renal function defined as creatinine clearance ≥ 60mL/min.
• Adequate liver function:
• Total bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN in patients with Gilbert's disease)
• ALT and AST ≤ 2.5 x ULN if no active liver involvement or ALT and AST ≤ 5 xULN with active liver involvement
• Albumin ≥3 g/dL
• Adequate hematologic and clotting function:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

You may not qualify if:

• Pregnant or breastfeeding persons who are not willing to stop breastfeeding. Due to the unknown safety profile of LGW16-03 in humans, and the potential for fetal or neonatal exposure through transplacental transfer or breast milk, breastfeeding is not allowed throughout the study and until at least 60 days after last dose.
• Nerve injury or dysfunction of any kind in the nerve to be imaged (e.g., diabetic neuropathy, multiple sclerosis, other neuropathy, traumatic nerve injury)
• Peripheral vascular disease requiring management a vascular surgeon.
• Prior surgery in the planned surgical region within the previous 365 days.
• Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events and/or heart failure within 1 year.
• Current evidence of renal or liver disease.
• History of fluorescein allergy.
• Direct administration of a local anesthetic agent in the region of the nerve to be imaged that could affect the motor or sensory function of the target nerve.
• Any other criteria deemed by the Principal Investigator that may prevent the participant from successfully completing the trial.

Sponsors & Collaborators

• Eric R. Henderson: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

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Central Study Contacts

Eric Henderson, MD

CONTACT

6036505133; Eric.R.Henderson@hitchcock.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study is a single-arm, open-label study of LGW16-03.

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)