Bevonescein for Improved Intraoperative Nerve Visualization to Improve Voice Outcomes in Thyroidectomy Patients

NCT07631650 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HCC 25-146
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Bevonescein (ALM-488) is a novel fluorescein-containing peptide that is intended as a visualization adjunct for the real-time enhanced structural delineation of major nerves during Head and Neck surgery to potentially improve patient outcomes.

Conditions

Head and Neck Disorder; Head and Neck Cancer

Keywords

vocal fold immobility; electromyographic (EMG) monitoring; thyroidectomy; intraoperative nerve visualization

Outcome Measures

Primary Outcomes (1)

• Change in Voice Handicap Index (VHI) scores

  Mean change in Voice Handicap Index (VHI) scores pre-operatively and post-operatively. Voice Handicap Index (VHI) is a 30-item self-administered questionnaire divided equally into three subscales designed to measure a patient's perceived handicap related to their voice disorder across functional, physical, and emotional domains. Functional (F) subscale (10 items) evaluates how voice problems affect daily activities, work, and social interactions (difficulty being understood on the phone or professional duty limitations). Physical (P) subscale (10 items) addresses physical sensations or characteristics of the voice problem (vocal fatigue, strain, or pitch changes). Emotional (E) subscale (10 items) assesses the emotional impact of a voice disorder (frustration, embarrassment, or anxiety) related to voice use. Item scores range from 0 (never) to 4 (always), with higher scores indicating a greater perceived handicap. Total VHI score: 0 to 120

  At baseline (before surgery) and at 28 days post-surgery

Secondary Outcomes (3)

• Time to nerve identification In Thyroid Surgery

  Day of Surgery

• Visualization Scoring System (VSS) scores

  Day of Surgery

• NERVE Questionnaire for Surgeons

  Day of Surgery

Study Arms (1)

Bevonescein (ALM 488) Infusion

EXPERIMENTAL

Drug: Bevonescein (ALM 488) Infusion

Interventions

Bevonescein (ALM 488) Infusion DRUG

Bevonescein is a synthetic peptide of 17 amino acids conjugated to a fluorescein derivative (5-carboxyfluorescein \[FAM\]) and can be visualized using instruments suitable for visualizing fluorescein. Bevonescein selectively binds to extracellular matrix of nerve tissue, increasing nerve visibility and enhancing structure delineation of nerve tissue, potentially reducing the time needed for surgeons to identify nerve tissue and reducing likelihood of nerve injury during thyroidectomy surgery.

Bevonescein (ALM 488) Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to undergo hemi thyroidectomy or total thyroidectomy for thyroid disease, including neoplasm
• Must be a minimum of 18 years old or older
• Must be able to give documented informed consent to participate in this study
• Must be a surgical candidate according to standard of care practices, as determined by the clinical judgement of the investigator
• Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception prior to study entry and during the course of the study. An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.
• Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:
• o Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.
• Willing and able to comply with all study procedures

You may not qualify if:

• Previous history of surgery and/or radiation to the head, neck, or shoulder
• Abnormal cardiac rhythm not controlled with medication
• The patient has a history of drug-related anaphylactic or severe allergic reactions (CTCAE grade 3+), at the discretion of the treating investigator
• Presence or history of any hypersensitivity to bevonescein (or fluorescein) 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 (MI) or cerebrovascular accident (CVA)
• 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
• Use of any Investigational Product or investigational medical device within 30 days prior to surgery date, or requirement for any investigational agent prior to completion of all scheduled study assessments
• The subject has current evidence of renal disease defined as glomerular filtration rate (GFR) \< 60 mL/min/1.73 m2

Sponsors & Collaborators

• Matthew Spector: lead
• Alume Biosciences, Inc.: collaborator

Study Sites (1)

UMPC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Matthew E Spector

  UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Ruth

CONTACT

412-623-8963; ruthj2@upmc.edu

Mel J Mendez, BS, BS

CONTACT

878-261-6071; mendezmj@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Division Chief, Head & Neck Surgical Oncology & Microvascular Reconstruction

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)