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Head and Neck DisorderPhase 2NCT07631650

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

A Phase 2 study testing Bevonescein (ALM 488) Infusion in people with Head and Neck Disorder and Head and Neck Cancer, run by Matthew Spector 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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Disorder, Head and Neck Cancer
What is being tested?
Bevonescein (ALM 488) Infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
18 Oct 2026to 31 Aug 2027
Phase
Phase 2
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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

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

Jennifer Ruth contact

412-623-8963

ruthj2@upmc.edu

Mel J Mendez, BS, BS contact

878-261-6071

mendezmj@upmc.edu

United States1 site, 1 recruiting

  • UMPC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Jennifer Ruth, RN, BSN, 412-623-8963, ruthj2@upmc.edu

    Mel J Mendez, BS, 878-261-6071, mendezmj@upmc.edu

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2 Trial of Systemic Administration of Bevonescein for Improved Intraoperative Nerve Visualization to Improve Voice Outcomes in Patients Undergoing Thyroidectomy

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.

Read the detailed description

Patients with thyroid disease undergoing thyroidectomy will receive systemic administration of bevonescein pre-operatively for intraoperative visualization of nerves. The voice outcomes of these patients will be assessed pre-operatively and post-operatively using patient questionnaires. This study aims to show that improved nerve visualization with bevonescein will be associated with clinically meaningful improvement in voice outcomes compared to a previously published studies.

Being tested
Bevonescein (ALM 488) Infusion
Keywords
vocal fold immobility, electromyographic (EMG) monitoring, thyroidectomy, intraoperative nerve visualization
Medical subject headings
Head and Neck Neoplasms

What participants receive

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

  • Bevonescein (ALM 488) InfusionDrug

    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.

Study groups in NCT07631650
Study groupRoleWhat they receive
Bevonescein (ALM 488) InfusionExperimentalNot described
Receives: Drug: Bevonescein (ALM 488) Infusion

What is being measured

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

  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

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

Secondary outcomes (3)

  1. Time to nerve identification In Thyroid Surgery

    Time to nerve identification after the superior pole vessels are taken down, which starts once the superior pole of the thyroid lobe is taken down and stops once the nerve is visualized and confirmed via nerve monitoring device per surgeon preference. In thyroidectomy, the superior pole vessels (typically the superior thyroid artery and its branches) are often dissected and mobilized before proceeding to the superior laryngeal nerve (SLN) identification. The SLN runs in close proximity to the superior thyroid artery, and thus removing the vessel can help expose the nerve and reduce the risk of injury. Earlier identification allows for protection of the nerve before further dissection.

    Measured: Day of Surgery

  2. Visualization Scoring System (VSS) scores

    Visualization Scoring System (VSS) is completed during the surgery based on the surgeon's visual assessment using the REVEAL 475 system when viewing the surgical field and the recurrent laryngeal nerve. The REVEAL device and supportive illumination system consists of the TriBeam light source (designed to create a 3-inch spot of white or blue light) and filter-modified surgical loupes. The VSS assessment comprises of a 4-point Likert scale for Nerve Conspicuity (NC) and Branching Delineation of the nerve as compared to its surrounding tissue. NC scores: 1- 'None', 2- 'Weak', 3- 'Clear' and 4- 'Clear and Bright'. Branching Delineation scores: 1- 'None', 2- 'Poorly visible', 3- 'Sufficiently visible' Clear' and 4- 'Excellent visibility'. Total scores: 1 to 32. Higher scores mean better visualization.

    Measured: Day of Surgery

  3. NERVE Questionnaire for Surgeons

    The NERVE questionnaire, consisting of 9 qualitative questions will be completed at the end of the surgical procedure by the surgeon. The questions measure the surgeon's perceived Confidence, Branching (ability to assess the nerve during the procedure), Discrimination (nerve distinction), Trajectory (ability to assess the nerve trajectory), Depth of penetration (ability to assess the nerve as it goes beyond the surgical surface) Convenience, Ease of use (of Bevonescein), Added value (added benefit/value towards nerve identification and/or localization for this patient) and Satisfaction overall. Possible responses to each question: Very satisfied, Satisfied, Somewhat satisfied, Neither satisfied nor dissatisfied, Somewhat dissatisfied, Dissatisfied, Very dissatisfied. No numerical scoring scale.

    Measured: Day of Surgery

Timeline

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

  1. First posted8 Jun 2026
  2. Study start18 Oct 2026 (estimated)
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07631650
Sponsor's protocol ID
HCC 25-146
Status last verified
Oct 2026
First submitted
27 May 2026
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevonescein (ALM 488) Infusion in people with Head and Neck Disorder and Head and Neck Cancer, run by Matthew Spector 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?

The sponsor lists 8 inclusion and 8 exclusion criteria. 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 19 Oct 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Jennifer Ruth (412-623-8963, ruthj2@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Voice Handicap Index (VHI) scores (time frame: At baseline (before surgery) and at 28 days post-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 NCT07631650.

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 19 Oct 2026.

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