Study of LGW16-03 To Identify Nerves

Inclusion criteria

• (All of the following criteria must be met by study participants to be eligible for study enrollment):
• 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:
• 5/5 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
• Platelet count ≥ 100 x 109/L
• Hemoglobin ≥ 8 g/dL or ≥ 5.6 mmol/L
• International Normalized Ratio (INR) ≤ 1.5 x ULN
• No growth factor support, transfusions, or albumin administration within 14 days of first dose of study treatment
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
• 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):
• 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.