Glow-in-the-Dark dye could help surgeons avoid nerve damage
NCT ID NCT07385430
First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times
Summary
This early-stage study tests a new dye called LGW16-03 that makes nerves glow during surgery. The goal is to see if it is safe and helps surgeons identify nerves to avoid injury. About 38 adults having open surgery will receive the dye by IV before their procedure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 38 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dartmouth-Hitchcock Medical Center
RECRUITINGLebanon, New Hampshire, 03756, United States
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