for people ages 16 years and up (full criteria)
study started
completion around



A feasibility study to evaluate the usability of the REVEAL 475 system in patients treated with bevonescein for nerve visualization during surgery.

Official Title

Feasibility Study- REVEAL 475 System for Bevonescein-Assisted Intra-Operative Visualization of Nerves in Head and Neck Surgery


The REVEAL 475 system will be evaluated for its ability to visualize nerve-fluorescence following bevonescein administration. All patients will receive a single dose of bevonescein 500 mg via IV infusion 1-5 hours before undergoing parotidectomy, thyroidectomy or neck dissection surgery.


Head and Neck Surgery, parotidectomy, thyroidectomy, neck dissection, ALM-488, bevonescein, nerve, fluorescence, intra-operative, real-time, REVEAL 475, REVEAL 475 System


You can join if…

Open to people ages 16 years and up

  • Minimum of 16 years of age.
  • Planning to undergo surgery in the Head and Neck.
  • Study participant's primary surgical treatment is parotidectomy or thyroidectomy (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.
  • Sexually active patients must be willing to use an acceptable method of contraception 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.

You CAN'T join if...

  • Patient has a history of prior surgery and/or radiation to the intended surgical site.
  • Patient has abnormal cardiac rhythm not controlled with medication.
  • Patient has moderate to severe renal impairment as indicated by a glomerular filtration rate (GFR) < 60 mL/min.
  • Patient has decreased hepatic function defined as AST/SGOT and ALT/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.
  • Patient has unresolved acute toxicity from prior anti-cancer therapy, alopecia, neuropathy <= Grade 2, as well as other non-acute and stable anti-cancer therapy toxicities are acceptable.
  • Patient has a history of fluorescein allergy.
  • Patient has a history of drug-related anaphylactic or severe allergic reactions.
  • Presense 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, or cerebrovascular accident.
  • 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.


  • Jacobs Medical Center at UC San Diego Health accepting new patients
    San Diego California 92093 United States
  • University of New Mexico not yet accepting patients
    Albuquerque New Mexico 87131 United States
  • MUSC- Hollings Cancer Center accepting new patients
    Charleston South Carolina 29425 United States


accepting new patients
Start Date
Completion Date
Alume Biosciences, Inc.
Phase 2 Head and Neck Surgery Research Study
Study Type
Expecting 80 study participants
Last Updated