Bevonescein for Intra-Operative Nerve Visualization in Head and Neck Surgery (NCT05377554) | Clinical Trial Compass
CompletedPhase 3
Bevonescein for Intra-Operative Nerve Visualization in Head and Neck Surgery
United States154 participantsStarted 2022-04-29
Plain-language summary
This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate bevonescein.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Must be a minimum of 16 years of age.
. Must be planning to undergo surgery in the Head and Neck.
. The study participant's primary surgical treatment is parotidectomy or thyroidectomy (unilateral or bilateral)/parathyroidectomy 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.
. Willing and able to comply with all study procedures.
. Sexually active patients must be willing to use an acceptable method of contraception (e.g., double barrier method) while participating in the study and for 30 days after receiving the last dose of bevonescein.
. Females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who have been in menopause at least 2 years, or had bilateral tubal ligation at least 1 year prior to screening, or who have had total hysterectomy.
Exclusion criteria
. The patient has a history of prior radiation or surgery to the intended surgical site.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. The patient has abnormal cardiac rhythm not controlled with medication.
. The patient has moderate to severe renal impairment as indicated by a glomerular filtration rate (GFR) \< 60 mL/min.
. The patient has decreased hepatic function defined as aspartate aminotransferase (AST)/serum glutamic/oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (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.
. The patient has unresolved acute toxicity from prior anti-cancer therapy grade 2 or higher, as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Alopecia, neuropathy ≤ Grade 2, as well as other non- acute and stable anti-cancer therapy toxicities are acceptable.
. The patient has a history of fluorescein allergy.
. The patient has a history of drug-related anaphylactic or severe allergic reactions.
. Presence 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.