Nerve-labeling dye to help protect major nerves during surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, single-arm, open-label trial evaluating the safety and tolerability of LGW16-03, a nerve-labeling fluorophore, in adults undergoing open-field orthopedic surgery. The study uses a dose-escalation approach (Part 1) followed by a dose expansion (Part 2) to identify a dose with acceptable safety and useful fluorescence contrast without affecting surgical decisions. Participants receive a one-time IV infusion 60–120 minutes before anesthesia, undergo standard-of-care procedures with intraoperative fluorescence imaging of the target nerve, and have safety, pharmacokinetic, and fluorescence data collected. A follow-up visit occurs roughly 30 days after surgery to monitor outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria (All of the following criteria must be met by study participants to be eligible for study enrollment):

1. 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.
2. Participants must be willing and able to provide informed consent for participation in the study and adhere to all study procedures.
3. 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:

   1. 5/5 motor strength in relevant muscle groups.
   2. Normal sensation on testing with a 5.07 Semmes-Weinstein filament or other valid testing method.
   3. No documented history of neuropathy of any kind.
4. Age ≥ 18 years old.
5. Medical clearance for surgery provided by a supervising medical provider (surgeon or primary care provider).
6. Adequate renal function defined as creatinine clearance ≥ 60mL/min.
7. Adequate liver function:

   1. Total bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN in patients with Gilbert's disease)
   2. ALT and AST ≤ 2.5 x ULN if no active liver involvement or ALT and AST ≤ 5 xULN with active liver involvement
   3. Albumin ≥3 g/dL
8. Adequate hematologic and clotting function:

   1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
   2. Platelet count ≥ 100 x 109/L
   3. Hemoglobin ≥ 8 g/dL or ≥ 5.6 mmol/L
   4. International Normalized Ratio (INR) ≤ 1.5 x ULN
9. No growth factor support, transfusions, or albumin administration within 14 days of first dose of study treatment
10. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
11. If of childbearing potential, must have a negative urine or serum pregnancy test and be using a medically acceptable form of contraception (e.g., hormonal birth control, intrauterine devices, double-barrier method) or abstinence.

Exclusion Criteria (Any of the following criteria would exclude a participant from study enrollment):

1. 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.
2. Nerve injury or dysfunction of any kind in the nerve to be imaged (e.g., diabetic neuropathy, multiple sclerosis, other neuropathy, traumatic nerve injury)
3. Peripheral vascular disease requiring management a vascular surgeon.
4. Prior surgery in the planned surgical region within the previous 365 days.
5. Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events and/or heart failure within 1 year.
6. Current evidence of renal or liver disease.
7. History of fluorescein allergy.
8. 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.
9. Any other criteria deemed by the Principal Investigator that may prevent the participant from successfully completing the trial.

Where it's running

• Dartmouth-Hitchcock Medical Center
  Lebanon, New Hampshire, United States Recruiting

Study contacts

• Study coordinator: Eric Henderson, MD
• Email: Eric.R.Henderson@hitchcock.org
• Phone: 6036505133

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.