Only 18 spots left

~18 spots leftby Oct 2025

Bevonescein for Nerve Visualization in Head and Neck Surgery

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Alume Biosciences, Inc.

Disqualifiers: Renal impairment, Hepatic dysfunction, Cardiac issues, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing a special tool called the REVEAL 475 system that helps surgeons see nerves better during certain neck surgeries. Patients will receive a dye called bevonescein that makes their nerves glow under this tool. This can help surgeons avoid damaging important nerves.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team or your doctor for guidance.

What data supports the effectiveness of the treatment Bevonescein for nerve visualization in head and neck surgery?

Research on similar treatments shows that using near-infrared (NIR) fluorophores can help surgeons see nerves more clearly during surgery, reducing the risk of accidental nerve damage. Studies have demonstrated that these fluorophores improve nerve visibility, even when nerves are hidden under tissue, which could lead to better surgical outcomes.¹ ² ³ ⁴ ⁵

Is Bevonescein safe for use in humans?

The research articles provided do not contain specific safety data for Bevonescein or its related names in humans.¹ ² ³ ⁵ ⁶

How is the REVEAL 475 System treatment different from other treatments for nerve visualization in head and neck surgery?

The REVEAL 475 System is unique because it uses a fluorescent labeling technique to enhance the visibility of nerves during surgery, which can help prevent accidental nerve damage. This system provides real-time visualization of nerves, even those buried beneath tissue, which is not possible with traditional white light imaging.¹ ³ ⁴ ⁵ ⁶

Research Team

Brett Berman, MD

Principal Investigator

Chief Medical Officer

Eligibility Criteria

This trial is for patients undergoing head and neck surgery who may benefit from enhanced nerve visualization. Specific eligibility criteria are not provided, but typically participants would need to be suitable candidates for the surgical procedure and the investigational imaging system.

Inclusion Criteria

I am able to become pregnant and will take pregnancy tests during the study.

Willing and able to provide written assent as required and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures

I agree to use birth control during and for 30 days after the study.

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Exclusion Criteria

Pregnant or breastfeeding at screening or planning to become pregnant (self or partner) at any time during the study

Use of any investigational product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments

I have mild side effects from cancer treatment, but they are stable.

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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-Surgery Preparation

Participants receive a single dose of bevonescein 500 mg via IV infusion 1-5 hours before surgery

1 day

Surgery

The REVEAL 475 system is used for nerve visualization during parotidectomy, thyroidectomy, or neck dissection surgery

1 day

Follow-up

Participants are monitored for plasma concentration of bevonescein and surgeon feedback is collected

0-12 hours after surgery

Treatment Details

Interventions

Bevonescein (Other)
REVEAL 475 System (Procedure)

Trial OverviewThe study is testing the REVEAL 475 system used with bevonescein, a dye that helps surgeons see nerves more clearly during operations. The goal is to assess how well this technology works in making surgeries safer by improving nerve visibility.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Single Arm (Bevonescein)Experimental Treatment2 Interventions

All patients will receive a single administration of bevonescein 500mg via IV infusion and the REVEAL 475 system will be used on all patients.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alume Biosciences, Inc.

Lead Sponsor

Trials

Recruited

390+

Ergomed

Industry Sponsor

Trials

Recruited

3,300+

Findings from Research

The new small molecule fluorophore GE3126 significantly improves nerve visualization during surgery, especially in minimally invasive procedures, by enhancing the contrast of small diameter nerves against surrounding tissues.

In preclinical studies, GE3126 showed no major adverse reactions in rats and provided clear nerve imaging in a porcine model within 5 to 10 minutes of injection, maintaining visibility for up to 80 minutes, suggesting it could help prevent nerve damage during operations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Intraoperative Visualization of Nerves through a Myelin-Binding Fluorophore and Dual-Mode Laparoscopic Imaging.Cotero, VE., Kimm, SY., Siclovan, TM., et al.[2020]

The use of fluorescently labeled nerve binding peptide NP41 during parotid gland cancer surgery in mice improved the identification and preservation of facial nerves compared to traditional white light methods.

Postoperative assessments indicated that facial nerve function was better preserved with fluorescent guidance, suggesting that NP41 can enhance surgical outcomes by reducing the risk of nerve injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved facial nerve identification during parotidectomy with fluorescently labeled peptide.Hussain, T., Nguyen, LT., Whitney, M., et al.[2018]