LGW16-03 for Nerve Identification

Overseen By Eric Henderson, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eric R. Henderson

Disqualifiers: Pregnancy, Nerve injury, Vascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, LGW16-03, to determine its safety and effectiveness in helping doctors visualize major nerves during open-field orthopedic surgery. The goal is to identify a safe dose that provides a clear image of the nerves to assist surgeons. The trial seeks individuals scheduled for this type of surgery who have normal nerve function. Participants will receive a one-time infusion of the drug before surgery and will attend follow-up visits. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor to ensure safety and compliance with the trial requirements.

What prior data suggests that LGW16-03 is safe for nerve identification?

Research has shown that LGW16-03, a new glowing dye for marking nerves, is in the early stages of testing for safety in humans. Previously, lab studies without human subjects found that the dye could successfully highlight nerve tissues, aiding visibility during surgery.

In this early human trial stage, the primary goal is to assess the safety of LGW16-03 and its potential for use without serious side effects. Participants receive a one-time dose before surgery, and doctors closely monitor their health and take blood samples to track how the dye moves through the body.

As this is an early-stage trial, there is limited human safety data. However, the progression to human testing indicates no major safety issues in earlier lab studies. Participants will be monitored carefully to ensure their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about LGW16-03 for nerve identification because it offers a novel approach to a common surgical challenge: accurately identifying nerves. Unlike traditional methods that rely on visual cues and anatomical knowledge, LGW16-03 is administered through a single IV infusion, potentially providing a more precise and less invasive way to highlight nerves during surgery. This could reduce the risk of nerve damage and improve surgical outcomes, making it a promising advancement over existing techniques.

What evidence suggests that LGW16-03 is effective for nerve identification?

Research has shown that LGW16-03, a special dye, can help highlight nerves during surgery. Early studies found that LGW16-03 makes nerve tissues glow, enhancing visibility. This improved visibility helps surgeons avoid nerve damage during operations. Tests with human tissues demonstrated similar success in identifying nerves, suggesting that LGW16-03 could be very helpful in real surgeries. Although data from human trials remains limited, these early results support the idea that LGW16-03 can make surgeries safer by clearly identifying nerves. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with sciatica who are undergoing open-field orthopaedic surgery. Participants must be eligible for the surgery and willing to have their vitals monitored, blood samples taken, and a follow-up visit about 30 days post-surgery.

Inclusion Criteria

I am cleared for surgery that involves a major nerve visible on scans.

Willing and able to provide informed consent and adhere to study procedures

Negative pregnancy test and medically acceptable contraception if of childbearing potential

Exclusion Criteria

History of fluorescein allergy

I have kidney or liver disease.

Any other criteria deemed by the Principal Investigator to hinder successful trial completion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a one-time intravenous infusion of LGW16-03 prior to their planned surgery

1 day

1 visit (in-person)

Surgery and Intraoperative Imaging

Fluorescence images of the major nerve are taken during surgery at regular intervals

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a follow-up visit approximately 30 days after surgery

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LGW16-03

Trial Overview

The study tests LGW16-03, a new nerve-labeling fluorophore given as a one-time IV infusion before surgery. The goals are to find the safest low dose that works best for imaging nerves during surgery and to understand how the drug moves through and leaves the body.

How Is the Trial Designed?

Group I: LGW16-03 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Eric R. Henderson

Lead Sponsor

Trials

1

Recruited

420+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07385430?term=TREATMENt

NCT07385430 | Study of LGW16-03 To Identify Nerves

The primary goal of this study is to determine the safety and tolerability of LGW16-03, a novel nerve-labeling fluorophore, in participants ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12833679/

Ex Vivo Human Tissue Functions as a Testing Platform ... - PMC

Systemic and topical administration of LGW16-03 yielded similar fluorescence labeling of nerve tissues. Both administration approaches provided ...

3.

digitalcommons.dartmouth.edu

digitalcommons.dartmouth.edu/cgi/viewcontent.cgi?article=1168&context=masters_theses

Preclinical Examination of a Nerve Specific Fluorophore ...

Nerve specific fluorophores such as LGW16-03 have yet to be used anywhere clinically and have far reaching applications in all subspecialities ...

4.

spiedigitallibrary.org

spiedigitallibrary.org/journals/journal-of-biomedical-optics/volume-28/issue-8/082802/Preclinical-evaluation-of-molecularly-targeted-fluorescent-probes-in-perfused-amputated/10.1117/1.JBO.28.8.082802.pdf

Preclinical evaluation of molecularly targeted fluorescent ...

After confirming successful perfusion, a standard dose. (1 mg∕mL concentration and 10 mL total) of a nerve-specific fluorophore (LGW16-03) was.

5.

researchgate.net

researchgate.net/publication/369257903_First_demonstration_of_a_novel_nerve-targeting_fluorophore_in_a_cohort_of_ex_vivo_human_tissues

First demonstration of a novel nerve-targeting fluorophore ...

Better nerve visualization and identification during surgery will improve outcomes and reduce nerve injuries. ... LGW16-03 performs in ...

6.

ctv.veeva.com

ctv.veeva.com/study/study-of-lgw16-03-to-identify-nerves

Study of LGW16-03 To Identify Nerves

The primary goal of this study is to determine the safety and tolerability of LGW16-03, a novel nerve-labeling fluorophore, in participants ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10065461/

First demonstration of a novel nerve-targeting fluorophore in a ...

Better visualization and identification with the use of a fluorescent contrast agent, such as LGW16–03, will likely improve surgical outcomes ...

8.

pharmaindustrial-india.com

pharmaindustrial-india.com/news/trace-biosciences-secures-fda-ind-clearance-for-first-nerve-specific-fluorescent-imaging-agent

Trace Biosciences Secures FDA IND Clearance for First ...

A real-time nerve imaging agent like LGW16-03, he added, could significantly reduce preventable nerve injuries and potentially transform ...