Study of LGW16-03 To Identify Nerves
Sponsor: Eric R. Henderson • ClinicalTrials.gov ID: NCT07385430
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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.
Interventions
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LGW16-03
(Drug)
LGW16-03 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.
Eligibility criteria
Conditions
Locations
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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