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NCT04420689 · REGISTRY CONDITION SEARCH

Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2025-05-08

Bevonescein to Highlight Nerves in Patients Undergoing Head \& Neck Surgery

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Safety - The Number of Patients With ALM-488 Related Adverse Events

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outcome · POSTED

Time of Peak ALM-488 Concentration in Plasma (Cmax)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: 1. A neoplasm located in the head and neck. 2. Primary surgical treatment is by parotidectomy, or thyroidectomy, or cervical neck dissection. 3. Can understand and is willing to sign a written informed consent document. 4. ≥18 years of age. 5. Life expectancy of at least 6 months. 6. Normal liver and kidney functions. 7. If of childbearing potential, must have a negative urine or serum pregnancy test and be using a medically acceptable form of contraception (e.g., hormonal birth control, intrauterine devices, double-barrier method) or abstinence. The subject, if male, must use a medically acceptable form of contraception (e.g. condom) or abstinence. 8. Plans to undergo head and neck surgery. Exclusion Criteria: 1. Prior radiation or chemotherapy for any prior head and neck neoplasm. 2. Open surgery in the ipsilateral head and neck within 1 year. 3. Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events and/or heart failure within 1 year. 4. Current evidence of renal disease. 5. Pregnant or breastfeeding. 6. Unresolved acute toxicity from prior anti-cancer therapy. 7. History of fluorescein allergy. 8. Any other criteria deemed by the Principal Investigator that may prevent the patient from successfully completing the trial.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    This arm of the study will include Dose Escalation/De-Escalation cohorts of Bevonescein (ALM-488).
    intervention Names
    1. Drug: Bevonescein
    label
    Dose Escalation/De-Escalation Cohorts
    type
    EXPERIMENTAL
  2. description
    This arm of the study will include Dose Timing cohorts of Bevonescein (ALM-488).
    intervention Names
    1. Drug: Bevonescein
    label
    Dose Timing Cohorts
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Dose Escalation/De-Escalation Cohorts
    2. Dose Timing Cohorts
    description
    Bevonescein Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.
    name
    Bevonescein
    other Names
    1. ALM-488
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
intervention Model Description
This is a Phase 1/Phase 2 study in patients undergoing Head \& Neck Surgery.
masking Info
masking
NONE
primary Purpose
PREVENTION
Enrollment
count
27
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    Time of peak ALM-488 concentration in plasma following intravenous ALM-488 infusion (hours).
    measure
    Time of Peak ALM-488 Concentration in Plasma (Cmax)
    time Frame
    28 (+5) days
primary Outcomes
  1. description
    The number of patients with ALM-488 related Adverse Events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
    measure
    Safety - The Number of Patients With ALM-488 Related Adverse Events
    time Frame
    28 (+5) days
Full study description
brief Summary
Bevonescein to Highlight Nerves in Patients Undergoing Head \& Neck Surgery
detailed Description
This study will evaluate the safety, tolerability, and efficacy of Bevonescein (ALM-488) administered as an intravenous (IV) infusion to patients undergoing head \& neck surgery. The study will also characterize the pharmacokinetics of Bevonescein (ALM-488) in this subject population and determine the dose of Bevonescein (ALM-488) needed to generate a fluorescence signal in nerve tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of Bevonescein (ALM-488) administration, relative to surgery, on fluorescence characteristics.
Source references
references
  1. citation
    Lee YJ, Orosco RK, Bouvet M, Richmon JD, Berman BJ, Crawford KL, Hom M, Nguyen QT, Rosenthal EL. Intraoperative nerve-specific fluorescence visualization in head and neck surgery: a Phase 1 trial. Nat Commun. 2025 Jul 2;16(1):6060. doi: 10.1038/s41467-025-60737-x.
    pmid
    40595556
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-c33c0b42733567dfaa39
      requested nct id
      NCT04420689
      primary nct id
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      source kind
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      source record id
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      payload
      clinical indication matching status
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      end exclusive
      true
      id
      nct-edge-c33c0b42733567dfaa39
      link basis
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      nct id
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      occurrences
      1. context exact
        NCT04420689
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        exact text
        NCT04420689
        start
        0
      offset unit
      unicode_code_points
      query cond
      Salivary Gland Cancer
      query disease state id
      ds-salivary-gland-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-salivary-gland-cancer-000.json
      source file sha256
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      source json pointer
      /studies/14/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      ab47913076b1b7006e015362b1a5ed4fd5e7224e5b0d67c451d4ef8bf54dc93d

    Preserved source evidence · Not medical advice