Study of LGW16-03 To Identify Nerves
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEric R. Henderson
About this trial
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.
Eligibility criteria
Qualifiers
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.
5/5 motor strength in relevant muscle groups.
Normal sensation on testing with a 5.07 Semmes-Weinstein filament or other valid testing method.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- LGW16-03
Treatment groups
38 Participants
are divided into 1 treatment groupSponsors and collaborators
Eric R. Henderson
Lead sponsor
Dartmouth-Hitchcock Medical Center
Sponsor institution
Oregon Health and Science University
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov