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AdultsPhase 1NCT07385430

Study of LGW16-03 To Identify Nerves

A Phase 1 study testing LGW16-03 in people with Adults and Open-field Surgery, run by Eric R. Henderson at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adults, Open-field Surgery, Major Nerve
What is being tested?
LGW16-03
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
8 Jul 2026to 1 Aug 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria (All of the following criteria must be met by study participants to be eligible for study enrollment):

  1. 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.
  2. Participants must be willing and able to provide informed consent for participation in the study and adhere to all study procedures.
  3. Intact motor and sensory function in the nerve to be imaged, as determined by physical exam performed by the operating surgeon or clinician on the study team, including:
  4. 5/5 motor strength in relevant muscle groups.
  5. Normal sensation on testing with a 5.07 Semmes-Weinstein filament or other valid testing method.
  6. No documented history of neuropathy of any kind.
  7. Age ≥ 18 years old.
  8. Medical clearance for surgery provided by a supervising medical provider (surgeon or primary care provider).
  9. Adequate renal function defined as creatinine clearance ≥ 60mL/min.
  10. Adequate liver function:
  11. Total bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN in patients with Gilbert's disease)
  12. ALT and AST ≤ 2.5 x ULN if no active liver involvement or ALT and AST ≤ 5 xULN with active liver involvement
  13. Albumin ≥3 g/dL
  14. Adequate hematologic and clotting function:
  15. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  16. Platelet count ≥ 100 x 109/L
  17. Hemoglobin ≥ 8 g/dL or ≥ 5.6 mmol/L
  18. International Normalized Ratio (INR) ≤ 1.5 x ULN
  19. No growth factor support, transfusions, or albumin administration within 14 days of first dose of study treatment
  20. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
  21. If of childbearing potential, must have a negative urine or serum pregnancy test and be using a medically acceptable form of contraception (e.g., hormonal birth control, intrauterine devices, double-barrier method) or abstinence.

Exclusion Criteria (Any of the following criteria would exclude a participant from study enrollment):

  1. 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.
  2. Nerve injury or dysfunction of any kind in the nerve to be imaged (e.g., diabetic neuropathy, multiple sclerosis, other neuropathy, traumatic nerve injury)
  3. Peripheral vascular disease requiring management a vascular surgeon.
  4. Prior surgery in the planned surgical region within the previous 365 days.
  5. Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events and/or heart failure within 1 year.
  6. Current evidence of renal or liver disease.
  7. History of fluorescein allergy.
  8. Direct administration of a local anesthetic agent in the region of the nerve to be imaged that could affect the motor or sensory function of the target nerve.
  9. Any other criteria deemed by the Principal Investigator that may prevent the participant from successfully completing the trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eric Henderson, MD contact

6036505133

Eric.R.Henderson@hitchcock.org

United States1 site, 1 recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

    Eric Henderson, MD, 603-650-5133, Eric.R.Henderson@hitchcock.org

    Recruiting

Other trials in United States

About this study

Official title: Phase 1 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 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.

Read the detailed description

This is a single-arm, open-label phase I study of LGW16-03, a novel nerve-labeling fluorophore created with the goal of reducing iatrogenic injury to nerves during medical procedures. This study will be conducted in two parts. Part 1-dose escalation- will follow a 3+3 dose-escalation trial design and we will investigate the safety of LGW16-03; pharmacokinetic and fluorescence contrast data will also be collected. Escalation will be stopped if dose-limiting toxicity (DLT) is encountered. Part 2-dose expansion-will continue safety and pharmacokinetic data collection and evaluate further the fluorescence contrast to inform dose. Eligible participants will be limited to healthy patients scheduled for open-field orthopaedic surgical procedures involving exposure of a major compound nerve (i.e., a named nerve with both motor and sensory function). Participants who are determined eligible and who provide informed consent will be administered a single intravenous dose of LGW16-03 on the day of surgery (D0) approximately 60-120 minutes before anticipated induction of anesthesia. Surgical procedures will be conducted per standard of care (SOC) and LGW16-03 will not be used for surgical decision-making. Intraoperative fluorescence imaging (iFI) will begin at the time of first exposure of the target nerve and will be repeated at approximately 30 +/- 15-minute intervals until the target nerve is no longer visible, or the procedure concludes. Imaging will be performed using an FDA-approved fluorescence imaging system (Zeiss Kinevo). At each time point, images of the exposed nerve and adjacent tissues-including muscle, adipose (fat), vasculature, fascia, skin, and/or tendon-will be captured and analyzed for fluorescence signal intensity. These data will be used to calculate nerve-to-background tissue ratios (NBTR) at each time point during the surgery. These data will provide assessment of LGW16-03's ability to provide clinically meaningful intraoperative illumination of the nerve relative to surrounding tissues at the doses being investigated. Additional data will be collected in the form of surveys completed: 1) in real time by the operating surgeon performing trial operations; and 2) surgeons shown images obtained during the surgery who are then asked about the conspicuity of nerve tissue. Up to 24 patients will take part in Part 1, up to 14 patients will take part in Part 2; a maximum of 38 patients will be enrolled in the entire study. Enrollment is expected to take <18 months. Total time for this protocol is estimated to be 24 months.

Being tested
LGW16-03
Keywords
Surgery, Nerve, Fluorescence imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LGW16-03Drug

    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 groups in NCT07385430
Study groupRoleWhat they receive
LGW16-03ExperimentalParticipants will receive a single IV infusion of the investigational drug (LGW16-03).
Receives: Drug: LGW16-03

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Immediately after infusion of the drug until the post-operative follow-up appointment which will occur approximately 30 days after surgery.

Secondary outcomes (2)

  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.

    Measured: 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).

    Measured: Regular blood draws will occur from infusion to 24 hours post-infusion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2026
  2. Study start8 Jul 2026
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
This study is a single-arm, open-label study of LGW16-03.
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07385430
Sponsor's protocol ID
02003082
Status last verified
Aug 2026
First submitted
13 Jan 2026
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Koller M, Qiu SQ, Linssen MD, Jansen L, Kelder W, de Vries J, Kruithof I, Zhang GJ, Robinson DJ, Nagengast WB, Jorritsma-Smit A, van der Vegt B, van Dam GM. Implementation and benchmarking of a novel analytical framework to clinically evaluate tumor-specific fluorescent tracers. Nat Commun. 2018 Sep 18;9(1):3739. doi: 10.1038/s41467-018-05727-y.

    PubMed 30228269

  • National Cancer Institute., Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, D.o.H.a.H. Services, Editor. 2017, National Institutes of Health, National Cancer Institute: Bethesda, MD.

  • Hart, S.G. and L.E. Staveland, Development of NASA-TLX (Task Load Index): Results of empirical and theoretical research. Advances in Psychology, 1988. 52: p. 139-183.

  • Lowndes BR, Forsyth KL, Blocker RC, Dean PG, Truty MJ, Heller SF, Blackmon S, Hallbeck MS, Nelson H. NASA-TLX Assessment of Surgeon Workload Variation Across Specialties. Ann Surg. 2020 Apr;271(4):686-692. doi: 10.1097/SLA.0000000000003058.

    PubMed 30247331

  • Henderson ER, Elliott J, Jiang S, Gitajn IL, Lee J, Gibbs S, Bouvet M, Mahadevan-Jansen A, Daly M, Streeter SS, Paulsen KD, Pogue BW, Samkoe KS, Singhal S. Proceduralist criteria for evaluating interface utility of novel imaging modalities in early phase clinical trials: evaluating the need for standardized criteria. Proc SPIE Int Soc Opt Eng. 2023 Jan-Feb;12361:123610F. doi: 10.1117/12.2650756. Epub 2023 Mar 14.

    PubMed 37034554

  • Ahlering TE, Eichel L, Skarecky D. Evaluation of long-term thermal injury using cautery during nerve sparing robotic prostatectomy. Urology. 2008 Dec;72(6):1371-4. doi: 10.1016/j.urology.2007.11.101. Epub 2008 Mar 3.

    PubMed 18313123

  • Echeverri A, Flexon PB. Electrophysiologic nerve stimulation for identifying the recurrent laryngeal nerve in thyroid surgery: review of 70 consecutive thyroid surgeries. Am Surg. 1998 Apr;64(4):328-33.

    PubMed 9544143

  • Li R, Liu Z, Pan Y, Chen L, Zhang Z, Lu L. Peripheral nerve injuries treatment: a systematic review. Cell Biochem Biophys. 2014 Apr;68(3):449-54. doi: 10.1007/s12013-013-9742-1.

    PubMed 24037713

  • Zhang J, Moore AE, Stringer MD. Iatrogenic upper limb nerve injuries: a systematic review. ANZ J Surg. 2011 Apr;81(4):227-36. doi: 10.1111/j.1445-2197.2010.05597.x. Epub 2010 Dec 23.

    PubMed 21418465

  • Burke S, Shorten GD. When pain after surgery doesn't go away.. Biochem Soc Trans. 2009 Feb;37(Pt 1):318-22. doi: 10.1042/BST0370318.

    PubMed 19143655

  • Gangadharan S, Sarkaria IN, Rice D, Murthy S, Braun J, Kucharczuk J, Predina J, Singhal S. Multiinstitutional Phase 2 Clinical Trial of Intraoperative Molecular Imaging of Lung Cancer. Ann Thorac Surg. 2021 Oct;112(4):1150-1159. doi: 10.1016/j.athoracsur.2020.09.037. Epub 2020 Nov 19.

    PubMed 33221195

  • Randall LM, Wenham RM, Low PS, Dowdy SC, Tanyi JL. A phase II, multicenter, open-label trial of OTL38 injection for the intra-operative imaging of folate receptor-alpha positive ovarian cancer. Gynecol Oncol. 2019 Oct;155(1):63-68. doi: 10.1016/j.ygyno.2019.07.010. Epub 2019 Jul 27.

    PubMed 31362825

  • Predina JD, Newton AD, Keating J, Dunbar A, Connolly C, Baldassari M, Mizelle J, Xia L, Deshpande C, Kucharczuk J, Low PS, Singhal S. A Phase I Clinical Trial of Targeted Intraoperative Molecular Imaging for Pulmonary Adenocarcinomas. Ann Thorac Surg. 2018 Mar;105(3):901-908. doi: 10.1016/j.athoracsur.2017.08.062. Epub 2018 Feb 15.

    PubMed 29397932

  • Hoogstins CE, Tummers QR, Gaarenstroom KN, de Kroon CD, Trimbos JB, Bosse T, Smit VT, Vuyk J, van de Velde CJ, Cohen AF, Low PS, Burggraaf J, Vahrmeijer AL. A Novel Tumor-Specific Agent for Intraoperative Near-Infrared Fluorescence Imaging: A Translational Study in Healthy Volunteers and Patients with Ovarian Cancer. Clin Cancer Res. 2016 Jun 15;22(12):2929-38. doi: 10.1158/1078-0432.CCR-15-2640.

    PubMed 27306792

  • Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401. doi: 10.1016/S1470-2045(06)70665-9.

    PubMed 16648043

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LGW16-03 in people with Adults and Open-field Surgery, run by Eric R. Henderson at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eric Henderson, MD (6036505133, Eric.R.Henderson@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07385430, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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