Study of LGW16-03 To Identify Nerves (NCT07385430) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Study of LGW16-03 To Identify Nerves
United States38 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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).
Exclusion criteria
✕
What they're measuring
1
Assess safety and tolerability of LGW16-03
Timeframe: Immediately after infusion of the drug until the post-operative follow-up appointment which will occur approximately 30 days after surgery.
. 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.