Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery
Completed · Phase 1/Phase 2
Conditions studied: Parotid Neoplasm, Thyroid Neoplasms, Head and Neck Neoplasms, Surgery, Nerve Injury, Imaging
In brief
Bevonescein to Highlight Nerves in Patients Undergoing Head \& Neck Surgery
Key facts
- Study ID
- NCT04420689
- Run by
- Alume Biosciences, Inc.
- People needed
- 27
- Starts
- 2020-06-18
- Expected to finish
- 2022-02-15
- Last updated by the study team
- 2025-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of California San Diego — San Diego, California, United States
- Stanford University — Stanford, California, United States
- Harvard-Mass Eye & Ear — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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