Status:
COMPLETED
Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery
Lead Sponsor:
Alume Biosciences, Inc.
Conditions:
Parotid Neoplasm
Thyroid Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 c...
Eligibility Criteria
Inclusion
- A neoplasm located in the head and neck.
- Primary surgical treatment is by parotidectomy, or thyroidectomy, or cervical neck dissection.
- Can understand and is willing to sign a written informed consent document.
- ≥18 years of age.
- Life expectancy of at least 6 months.
- Normal liver and kidney functions.
- 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.
- Plans to undergo head and neck surgery.
Exclusion
- Prior radiation or chemotherapy for any prior head and neck neoplasm.
- Open surgery in the ipsilateral head and neck within 1 year.
- Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events and/or heart failure within 1 year.
- Current evidence of renal disease.
- Pregnant or breastfeeding.
- Unresolved acute toxicity from prior anti-cancer therapy.
- History of fluorescein allergy.
- Any other criteria deemed by the Principal Investigator that may prevent the patient from successfully completing the trial.
Key Trial Info
Start Date :
June 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04420689
Start Date
June 18 2020
End Date
February 15 2022
Last Update
May 8 2025
Active Locations (3)
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1
University of California San Diego
San Diego, California, United States, 92037
2
Stanford University
Stanford, California, United States, 94305
3
Harvard-Mass Eye & Ear
Boston, Massachusetts, United States, 02114