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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
LGW16-03
DrugLGW16-03 is a non-biological medical imaging agent classified as a contrast agent, consistent with FDA definitions. It is intended to improve intraoperative visualization of specific tissues-namely, peripheral nerves-by enhancing the relative difference in fluorescence signal intensity between nerve and adjacent tissues.
Treatment groups
38 Participants
are divided into 1 treatment groupGroup A: LGW16-03Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Assess safety and tolerability of LGW16-03
This study's primary outcome is safety, which will be evaluated by the occurrence of treatment-related adverse events, with attention to frequency and severity as determined by CTCAE v5.0.
Time frame
Immediately after infusion of the drug until the post-operative follow-up appointment which will occur approximately 30 days after surgery.Secondary outcomes
1
Assess dose of LGW16-03
This study's first secondary outcome is study drug dose, which will be evaluated by identifying the lowest dose that provides useful fluorescence contrast, which is measured via the nerve-to-background fluorescence contrast ratio.
Time frame
Immediately after infusion of the drug until the post-operative follow-up appointment which will occur approximately 30 days after surgery.2
Assess time of peak LGW16-03 concentration
The study's second secondary outcome is to assess time of peak LGW16-03 concentration in plasma (Cmax) following intravenous LGW16-03 infusion (hours).
Time frame
Regular blood draws will occur from infusion to 24 hours post-infusion.Other outcomes
1
Evaluate the ability of LGW16-03 to generate detectable fluorescence signal in exposed nerve tissue during surgery.
Using the Kinevo 900 imager (Carl Zeiss AG, Germany; FDA-approved fluorescence imaging system), fluorescence images will be taken of the surgical field at regular intervals.
Time frame
From when major nerve is first visible during surgery, approximately every 30 minutes until surgery ends.2
Assess operating surgeon-reported experience in identifying nerve tissue with LGW16-03
Visual-analog scale (VAS)-based questions of nerve visualization
Time frame
Operating surgeon experience will be evaluated immediately following surgery.3
Assess operating surgeon-reported experience in identifying nerve tissue with LGW16-03
Likert scale-based questions of nerve visualization
Time frame
Operating surgeon experience will be evaluated immediately following surgery.4
Assess operating surgeon-reported experience in identifying nerve tissue with LGW16-03
Task load index (NASA-TLX) scores, where higher scores indicate higher task load.
Time frame
Operating surgeon experience will be evaluated immediately following surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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