Study of LGW16-03 To Identify Nerves

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Eric R. Henderson
Study ID
NCT07385430
Phase
PHASE1
Status
Recruiting
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Conditions

  • Adults
  • Major Nerve
  • Open-field Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 15, 2026
Status verified
Mar 2026
Primary completion
Aug 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: LGW16-03
    Participants will receive a single IV infusion of the investigational drug (LGW16-03).

Primary Outcome Measure

Assess safety and tolerability of LGW16-03 [ Time Frame: Immediately after infusion of the drug until the post-operative follow-up appointment which will occur approximately 30 days after surgery. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756
Eric Henderson, MD
[email protected]
603-650-5133

Find similar trials in Lebanon, NH

By research site
Dartmouth-Hitchcock Medical Center· Lebanon, NH

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