Using bevonescein to improve nerve visualization in head and neck surgeries

Feasibility Study- REVEAL 475 System for Bevonescein-Assisted Intra-Operative Visualization of Nerves in Head and Neck Surgery

This study is testing whether a new dye called bevonescein can help doctors see nerves better during head and neck surgeries to improve safety and outcomes for patients.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: Alume Biosciences, Inc. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (San Diego, California)
• Trial ID: NCT06227585 on ClinicalTrials.gov

What this trial studies

This feasibility study evaluates the effectiveness of the REVEAL 475 system in visualizing nerves during head and neck surgeries after administering bevonescein. Patients scheduled for parotidectomy, thyroidectomy, or neck dissection will receive a single intravenous dose of bevonescein prior to surgery. The study aims to assess the usability of this nerve visualization technique to enhance surgical outcomes. By monitoring nerve fluorescence, the study seeks to improve surgical precision and reduce complications.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 16 and older who are scheduled for parotidectomy, thyroidectomy, or neck dissection.

Not a fit: Patients with a history of prior surgery or radiation to the intended surgical site may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced nerve damage during head and neck surgeries.

How similar studies have performed: While nerve visualization techniques have been explored, this specific approach using bevonescein and the REVEAL 475 system is novel and has not been widely tested.

Eligibility criteria

Inclusion Criteria:

* Minimum of 16 years of age.
* Planning to undergo surgery in the Head and Neck.
* Study participant's primary surgical treatment is parotidectomy or thyroidectomy (unilateral or bilateral) or cervical neck dissection.
* 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.
* Sexually active patients must be willing to use an acceptable method of contraception while participating in the study and for 30 days after receiving bevonescein.
* Females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study.

Exclusion Criteria:

* Patient has a history of prior surgery and/or radiation to the intended surgical site.
* Patient has abnormal cardiac rhythm not controlled with medication.
* Patient has moderate to severe renal impairment as indicated by a glomerular filtration rate (GFR) \< 60 mL/min.
* Patient has decreased hepatic function defined as AST/SGOT and ALT/SGPT that is higher than 20% of the institution's normal laboratory limits, and/or the patient has elevated total bilirubin that is higher than 20% of the institution's normal laboratory limits.
* Patient has unresolved acute toxicity from prior anti-cancer therapy, alopecia, neuropathy \<= Grade 2, as well as other non-acute and stable anti-cancer therapy toxicities are acceptable.
* Patient has a history of fluorescein allergy.
* Patient has a history of drug-related anaphylactic or severe allergic reactions.
* Presense or history of any hypersensitivity to bevonescein or its excipients that, in the judgment of the Investigator, places the patient at increased risk for adverse effects.
* Presence of a concurrent disease or condition that may interfere with study participation including recent (within 6 months of screening) NYHA Class III or IV heart failure, myocardial infarction, or cerebrovascular accident.
* Presence or history of any condition, that in the view of the Investigator, places the patient at high risk of poor treatment compliance or of not completing the study.
* 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.

Where this trial is running

San Diego, California

• Jacobs Medical Center at UC San Diego Health — San Diego, California, United States (Recruiting)

Study contacts

• Study coordinator: Brett Berman, MD

Conditions Head and Neck Surgery; parotidectomy; thyroidectomy; neck dissection; ALM-488; bevonescein; nerve; fluorescence