SurgeryPhase 3NCT05377554
Bevonescein for Intra-Operative Nerve Visualization in Head and Neck Surgery
A Phase 3 study testing Bevonescein, Intraoperative Visualization using White Light Reflectance (WLR) with Fluorescence (FL) Overlay and Intra-operative Visualization using White Light Reflectance (WLR) in people with Surgery, run by Alume Biosciences, Inc. at 1 site in United States.
Trial summary
This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate bevonescein. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Bevonescein, Intraoperative Visualization using White Light Reflectance (WLR) with Fluorescence (FL) Overlay and Intra-operative Visualization using White Light Reflectance (WLR)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2022to 24 Nov 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must be a minimum of 16 years of age.
- Must be planning to undergo surgery in the Head and Neck.
- The study participant's primary surgical treatment is parotidectomy or thyroidectomy (unilateral or bilateral)/parathyroidectomy 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.
- Willing and able to comply with all study procedures.
- Sexually active patients must be willing to use an acceptable method of contraception (e.g., double barrier method) while participating in the study and for 30 days after receiving the last dose of bevonescein.
- Females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who have been in menopause at least 2 years, or had bilateral tubal ligation at least 1 year prior to screening, or who have had total hysterectomy.
Who cannot join
- The patient has a history of prior radiation or surgery to the intended surgical site.
- The patient has abnormal cardiac rhythm not controlled with medication.
- The patient has moderate to severe renal impairment as indicated by a glomerular filtration rate (GFR) < 60 mL/min.
- The patient has decreased hepatic function defined as aspartate aminotransferase (AST)/serum glutamic/oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (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.
- The patient has unresolved acute toxicity from prior anti-cancer therapy grade 2 or higher, as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Alopecia, neuropathy ≤ Grade 2, as well as other non- acute and stable anti-cancer therapy toxicities are acceptable.
- The patient has a history of fluorescein allergy.
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- The patient has a history of drug-related anaphylactic or severe allergic reactions.
- Presence 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) New York Heart Association (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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bevonescein (ALM-488) For Intra-Operative Visualization of Nerves In Head And Neck Surgery
This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate bevonescein.
Read the detailed description
This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate bevonescein, a visualization adjunct for the real-time enhanced structural delineation of major nerves, in patients undergoing surgery of the Head and Neck.
- Conditions
- Surgery
- Being tested
- Bevonescein, Intraoperative Visualization using White Light Reflectance (WLR) with Fluorescence (FL) Overlay, Intra-operative Visualization using White Light Reflectance (WLR)
- Keywords
- head and neck surgery, malignancy, thyroidectomy, parotidectomy, neck dissection, fluorescence, nerve, ALM-488, intra-operative, real-time, parathyroidectomy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevonesceinDrug
Also called ALM-488
Bevonescein will be infused during the pre-operative period.
Intraoperative Visualization using White Light Reflectance (WLR) with Fluorescence (FL) OverlayOther
Intra-operative real time nerve visualization will be undertaken using WLR with FL Overlay.
Intra-operative Visualization using White Light Reflectance (WLR)Other
Intra-operative real time nerve visualization will be undertaken using WLR.
| Study group | Role | What they receive |
|---|---|---|
| ALM-488-002a WLR only | Experimental | Patients with a preoperative diagnosis of malignancy will be assigned to study ALM-488-002a. All patients will receive ALM-488 infusion. Intraoperative nerve visualization will be performed using WLR only. Receives: Drug: Bevonescein; Other: Intra-operative Visualization using White Light Reflectance (WLR) |
| ALM-488-002a WLR with FL Overlay | Experimental | Patients with a preoperative diagnosis of malignancy will be assigned to study ALM-488-002a. All patients will receive ALM-488 infusion. Intraoperative nerve visualization will be performed using WLR with FL Overlay. Receives: Drug: Bevonescein; Other: Intraoperative Visualization using White Light Reflectance (WLR) with Fluorescence (FL) Overlay |
| ALM-488-002b WLR only | Experimental | Patients without a preoperative diagnosis of malignancy will be assigned to study ALM-488-002b. All patients will receive ALM-488 infusion. Intraoperative nerve visualization will be performed using WLR only. Receives: Drug: Bevonescein; Other: Intra-operative Visualization using White Light Reflectance (WLR) |
| ALM-488-002b WLR with FL Overlay | Experimental | Patients without a preoperative diagnosis of malignancy will be assigned to study ALM-488-002b. All patients will receive ALM-488 infusion. Intraoperative nerve visualization will be performed using WLR with FL Overlay. Receives: Drug: Bevonescein; Other: Intraoperative Visualization using White Light Reflectance (WLR) with Fluorescence (FL) Overlay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve Conspicuity
Nerve Conspicuity will be compared between WLR and WLR with FL Overlay Using the Visualization Scoring System. The Nerve Conspicuity scale is a 4-point Likert scale where 1 is the least preferable and 4 is the most preferable.
Measured: During surgery
Length Measurement
Nerve Length Measurement in mm will be compared between WLR and WLR with FL Overlay Using a Metric Ruler. Higher values are better than lower values.
Measured: During Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start29 Apr 2022
- Primary completion27 Oct 2025
- Study completion24 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alume Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brett Berman MD FACC, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377554
- Sponsor's protocol ID
- ALM-488-002
- Status last verified
- Oct 2026
- First submitted
- 12 May 2022
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevonescein (ALM-488) For Intra-Operative Visualization of Nerves In Head And Neck Surgery
- ClinicalTrials.gov ID
- NCT05377554
- Acronym / sponsor ID
- ALM-488-002
- Conditions
- Surgery
- Keywords
- head and neck surgery, malignancy, thyroidectomy, parotidectomy, neck dissection, fluorescence, nerve, ALM-488
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Alume Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate bevonescein.
Detailed description
This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate bevonescein, a visualization adjunct for the real-time enhanced structural delineation of major nerves, in patients undergoing surgery of the Head and Neck.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies.
| Arm | Type | Receives |
|---|---|---|
| ALM-488-002a WLR only | Experimental | Drug: Bevonescein, Other: Intra-operative Visualization using White Light Reflectance (WLR)Patients with a preoperative diagnosis of malignancy will be assigned to study ALM-488-002a. All patients will receive ALM-488 infusion. Intraoperative nerve visualization will be performed using WLR only. |
| ALM-488-002a WLR with FL Overlay | Experimental | Drug: Bevonescein, Other: Intraoperative Visualization using White Light Reflectance (WLR) with Fluorescence (FL) OverlayPatients with a preoperative diagnosis of malignancy will be assigned to study ALM-488-002a. All patients will receive ALM-488 infusion. Intraoperative nerve visualization will be performed using WLR with FL Overlay. |
| ALM-488-002b WLR only | Experimental | Drug: Bevonescein, Other: Intra-operative Visualization using White Light Reflectance (WLR)Patients without a preoperative diagnosis of malignancy will be assigned to study ALM-488-002b. All patients will receive ALM-488 infusion. Intraoperative nerve visualization will be performed using WLR only. |
| ALM-488-002b WLR with FL Overlay | Experimental | Drug: Bevonescein, Other: Intraoperative Visualization using White Light Reflectance (WLR) with Fluorescence (FL) OverlayPatients without a preoperative diagnosis of malignancy will be assigned to study ALM-488-002b. All patients will receive ALM-488 infusion. Intraoperative nerve visualization will be performed using WLR with FL Overlay. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Must be a minimum of 16 years of age.
- Must be planning to undergo surgery in the Head and Neck.
- The study participant's primary surgical treatment is parotidectomy or thyroidectomy (unilateral or bilateral)/parathyroidectomy 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.
- Willing and able to comply with all study procedures.
Key exclusion criteria (12 listed)
- The patient has a history of prior radiation or surgery to the intended surgical site.
- The patient has abnormal cardiac rhythm not controlled with medication.
- The patient has moderate to severe renal impairment as indicated by a glomerular filtration rate (GFR) < 60 mL/min.
- The patient has decreased hepatic function defined as aspartate aminotransferase (AST)/serum glutamic/oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (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.
- The patient has unresolved acute toxicity from prior anti-cancer therapy grade 2 or higher, as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Alopecia, neuropathy ≤ Grade 2, as well as other non- acute and stable anti-cancer therapy toxicities are acceptable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevonesceinAlso: ALM-488Bevonescein will be infused during the pre-operative period. | Drug | ALM-488-002a WLR only, ALM-488-002a WLR with FL Overlay, ALM-488-002b WLR only, ALM-488-002b WLR with FL Overlay |
| Intraoperative Visualization using White Light Reflectance (WLR) with Fluorescence (FL) OverlayIntra-operative real time nerve visualization will be undertaken using WLR with FL Overlay. | Other | ALM-488-002a WLR with FL Overlay, ALM-488-002b WLR with FL Overlay |
| Intra-operative Visualization using White Light Reflectance (WLR)Intra-operative real time nerve visualization will be undertaken using WLR. | Other | ALM-488-002a WLR only, ALM-488-002b WLR only |
Primary outcome
Nerve Conspicuity
Time frame: During surgery
Nerve Conspicuity will be compared between WLR and WLR with FL Overlay Using the Visualization Scoring System. The Nerve Conspicuity scale is a 4-point Likert scale where 1 is the least preferable and 4 is the most preferable.
Length Measurement
Time frame: During Surgery
Nerve Length Measurement in mm will be compared between WLR and WLR with FL Overlay Using a Metric Ruler. Higher values are better than lower values.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett Berman MD FACC study director
Chief Medical Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bevonescein, Intraoperative Visualization using White Light Reflectance (WLR) with Fluorescence (FL) Overlay and Intra-operative Visualization using White Light Reflectance (WLR) in people with Surgery, run by Alume Biosciences, Inc. 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 7 inclusion and 12 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: finished, as of the sponsor's last update on 8 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve Conspicuity (time frame: During surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.