Feasibility Study for Bevonescein-Assisted Nerve Visualization in Head & Neck Surgery
a study on Head and Neck Surgery
Summary
- Eligibility
- for people ages 16 years and up (full criteria)
- Location
- at UCSD
- Dates
- study startedcompletion around
Description
Summary
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
Details
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.
Keywords
Head and Neck Surgery, parotidectomy, thyroidectomy, neck dissection, ALM-488, bevonescein, nerve, fluorescence, intra-operative, real-time, REVEAL 475, REVEAL 475 System
Eligibility
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.
Location
- Jacobs Medical Center at UC San Diego Health
accepting new patients
San Diego California 92093 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Alume Biosciences, Inc.
- ID
- NCT06227585
- Phase
- Phase 2 Head and Neck Surgery Research Study
- Study Type
- Interventional
- Participants
- Expecting 80 study participants
- Last Updated