Head and Neck SurgeryPhase 2/3NCT06227585
Feasibility and Efficacy Study for Bevonescein-Assisted Nerve Visualization in Head & Neck Surgery
A Phase 2/3 study testing REVEAL 475 System and Bevonescein in people with Head and Neck Surgery, run by Alume Biosciences, Inc. at 1 site in United States.
Trial summary
A Part 1 Phase 2 feasibility study to characterize the feasibility of using the REVEAL 475 system by obtaining surgeon perspective on illumination and ease of use. A Part 2 Phase 3 safety and efficacy study to evaluate conspicuity of the identified nerve due to bevonescein through the use of the Visualization Scoring… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Head and Neck Surgery
- What is being tested?
- REVEAL 475 System and Bevonescein
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2023to 5 Jan 2026
- Phase
- Phase 2/3
- 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/ parathyroidectomy (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.
- 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 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 surgery and/or radiation 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 nonacute and stable anti-cancer therapy toxicities are acceptable.
- The patient has a history of fluorescein allergy.
Show all 13Show fewer
- 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) 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.
- In patients with confirmed Gilbert Syndrome, total serum bilirubin may be elevated up to 3x the institution's normal laboratory limits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2/3 Safety and Efficacy Trial of the REVEAL 475 System for Bevonescein-Assisted Intra-Operative Visualization of Nerves in Head and Neck Surgery
A Part 1 Phase 2 feasibility study to characterize the feasibility of using the REVEAL 475 system by obtaining surgeon perspective on illumination and ease of use.
A Part 2 Phase 3 safety and efficacy study to evaluate conspicuity of the identified nerve due to bevonescein through the use of the Visualization Scoring System (VSS).
Read the detailed description
Part 1 Phase 2: All patients will receive a single dose of bevonescein 500 mg via IV infusion 1-5 hours before undergoing parotidectomy, thyroidectomy, parathyroidectomy or neck dissection surgery. The REVEAL 475 system will be evaluated for its ability to visualize nerve-fluorescence following bevonescein administration.
Part 2 Phase 3: All patients receive a single dose of bevonescein 500mg via IV infusion 1-5 hours before undergoing parotidectomy, thyroidectomy, parathyroidectomy or neck dissection surgery. During the surgery the REVEAL 475 system will be used to assess through the use of the Visualization Scoring System (VSS).
- Conditions
- Head and Neck Surgery
- Being tested
- REVEAL 475 System, Bevonescein
- Keywords
- parotidectomy, thyroidectomy, neck dissection, ALM-488, bevonescein, nerve, fluorescence, head and neck surgery, intra-operative, real-time, REVEAL 475, parathyroidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REVEAL 475 SystemDevice
The REVEAL 475 system will be evaluated for its ability to visualize nerve-fluorescence following bevonescein administration.
BevonesceinDrug
Also called ALM-488
All patients will receive a single dose of bevonescein 500 mg via IV infusion 1-5 hours before surgery.
| Study group | Role | What they receive |
|---|---|---|
| ALM-488-003 Part 1 Phase 2 Single Arm (Bevonescein) | Experimental | All patients will receive a single administration of bevonescein 500mg via IV infusion and the REVEAL 475 system will be used on all patients. Receives: Device: REVEAL 475 System; Drug: Bevonescein |
| ALM-488-003 Part 2 Phase 3 WLR (Bevonescein) | Experimental | All patients will receive a single administration of bevonescein 500mg via IV infusion and the REVEAL 475 system will be used on all patients. Receives: Device: REVEAL 475 System; Drug: Bevonescein |
| ALM-488-003 Part 2 Phase 3 WLR with FL Overlay (Bevonescein) | Experimental | All patients will receive a single administration of bevonescein 500mg via IV infusion and the REVEAL 475 system will be used on all patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 Phase 2 Surgeon perspective on REVEAL 475 system blue light illumination
Surgeon assessment to questions
Measured: Immediately after surgery
Part 1 Phase 2 Surgeon perspective on REVEAL 475 system ease of use
Surgeon to provide responses to questions on a Likert scale 1-5 where a higher score means a better outcome
Measured: Immediately after surgery
Part 2 Phase 3 To demonstrate the efficacy of bevonescein to improve the Nerve Conspicuity
Mean NC score assessed by the surgeon for all applicable index nerves per patient
Measured: During Surgery
Part 2 Phase 3 To demonstrate the efficacy of bevonescein to improve the Length Measurement of nerves that can be visualized
Mean LM score assessed by the surgeon for all applicable index nerves per patient
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 posted29 Jan 2024
- Study start29 Nov 2023
- Primary completion24 Oct 2025
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alume Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brett Berman MD FACC, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227585
- Sponsor's protocol ID
- ALM-488-003
- Status last verified
- Oct 2026
- First submitted
- 16 Nov 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
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
- Phase 2/3 Safety and Efficacy Trial of the REVEAL 475 System for Bevonescein-Assisted Intra-Operative Visualization of Nerves in Head and Neck Surgery
- ClinicalTrials.gov ID
- NCT06227585
- Acronym / sponsor ID
- ALM-488-003
- Conditions
- Head and Neck Surgery
- Keywords
- parotidectomy, thyroidectomy, neck dissection, ALM-488, bevonescein, nerve, fluorescence, head and neck surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Alume Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 29 Jan 2024 (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.
A Part 1 Phase 2 feasibility study to characterize the feasibility of using the REVEAL 475 system by obtaining surgeon perspective on illumination and ease of use.
A Part 2 Phase 3 safety and efficacy study to evaluate conspicuity of the identified nerve due to bevonescein through the use of the Visualization Scoring System (VSS).
Detailed description
Part 1 Phase 2: All patients will receive a single dose of bevonescein 500 mg via IV infusion 1-5 hours before undergoing parotidectomy, thyroidectomy, parathyroidectomy or neck dissection surgery. The REVEAL 475 system will be evaluated for its ability to visualize nerve-fluorescence following bevonescein administration.
Part 2 Phase 3: All patients receive a single dose of bevonescein 500mg via IV infusion 1-5 hours before undergoing parotidectomy, thyroidectomy, parathyroidectomy or neck dissection surgery. During the surgery the REVEAL 475 system will be used to assess through the use of the Visualization Scoring System (VSS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALM-488-003 Part 1 Phase 2 Single Arm (Bevonescein) | Experimental | Device: REVEAL 475 System, Drug: BevonesceinAll patients will receive a single administration of bevonescein 500mg via IV infusion and the REVEAL 475 system will be used on all patients. |
| ALM-488-003 Part 2 Phase 3 WLR (Bevonescein) | Experimental | Device: REVEAL 475 System, Drug: BevonesceinAll patients will receive a single administration of bevonescein 500mg via IV infusion and the REVEAL 475 system will be used on all patients. |
| ALM-488-003 Part 2 Phase 3 WLR with FL Overlay (Bevonescein) | Experimental | –All patients will receive a single administration of bevonescein 500mg via IV infusion and the REVEAL 475 system will be used on all patients. |
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/ parathyroidectomy (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.
- Willing and able to comply with all study procedures.
Key exclusion criteria (13 listed)
- The patient has a history of prior surgery and/or radiation 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 nonacute 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 |
|---|---|---|
| REVEAL 475 SystemThe REVEAL 475 system will be evaluated for its ability to visualize nerve-fluorescence following bevonescein administration. | Device | ALM-488-003 Part 1 Phase 2 Single Arm (Bevonescein), ALM-488-003 Part 2 Phase 3 WLR (Bevonescein) |
| BevonesceinAlso: ALM-488All patients will receive a single dose of bevonescein 500 mg via IV infusion 1-5 hours before surgery. | Drug | ALM-488-003 Part 1 Phase 2 Single Arm (Bevonescein), ALM-488-003 Part 2 Phase 3 WLR (Bevonescein) |
Primary outcome
Part 1 Phase 2 Surgeon perspective on REVEAL 475 system blue light illumination
Time frame: Immediately after surgery
Surgeon assessment to questions
Part 1 Phase 2 Surgeon perspective on REVEAL 475 system ease of use
Time frame: Immediately after surgery
Surgeon to provide responses to questions on a Likert scale 1-5 where a higher score means a better outcome
Part 2 Phase 3 To demonstrate the efficacy of bevonescein to improve the Nerve Conspicuity
Time frame: During Surgery
Mean NC score assessed by the surgeon for all applicable index nerves per patient
Part 2 Phase 3 To demonstrate the efficacy of bevonescein to improve the Length Measurement of nerves that can be visualized
Time frame: During Surgery
Mean LM score assessed by the surgeon for all applicable index nerves per patient
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.
Related trials for Head and Neck Surgery
RecruitingPhase 2
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
RecruitingPhase 2
Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma
Not yet recruitingPhase 4
Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive Surgery
Surgical Wound Infection, Neck Infection
RecruitingPhase 3
Modular Robot-Assisted Versus Conventional Minimally Invasive Esophagectomy for Esophageal Cancer
Esophageal Cancer
Active, not recruitingPhase 2
Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery
Head and Neck Cancer
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, MD 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 2/3 study testing REVEAL 475 System and Bevonescein in people with Head and Neck 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 13 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 combined 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.
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?
Part 1 Phase 2 Surgeon perspective on REVEAL 475 system blue light illumination (time frame: Immediately after surgery). The study lists 4 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.