Head and Neck Disorder study: Bevonescein
Official title Bevonescein for Improved Intraoperative Nerve Visualization to Improve Voice Outcomes in Thyroidectomy Patients
ClinicalTrials.gov ID: NCT07631650
What this study is testing
What is Bevonescein (ALM 488) Infusion?
Bevonescein (ALM 488) Infusion is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for head and neck disorder.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a fluorescein dye called Bevonescein can help doctors see major nerves better during thyroid surgery.
- Who it's for
- You may be able to join if you are having thyroid surgery for head or neck cancer.
- What's involved
- You would receive an injection of Bevonescein during your operation. The dye helps the surgeon see nerves in real time.
- Time commitment
- The study involves only the time of your surgery and no extra visits.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Scheduled to undergo hemi thyroidectomy or total thyroidectomy for thyroid disease, including neoplasm
- Must be a minimum of 18 years old or older
- Must be able to give documented informed consent to participate in this study
- Must be a surgical candidate according to standard of care practices, as determined by the clinical judgement of the investigator
- Sexually active fertile people and their partners must agree to use highly effective methods of contraception prior to study entry and during the...
You likely can't join if
- Previous history of surgery and/or radiation to the head, neck, or shoulder
- Abnormal cardiac rhythm not controlled with medication
- The patient has a history of drug-related anaphylactic or severe allergic reactions (CTCAE grade 3+), at the discretion of the treating investigator
- Presence or history of any hypersensitivity to bevonescein (or fluorescein) or its excipients that, in the judgment of the investigator, places the...
- Presence of a concurrent disease or condition that may interfere with study participation including recent (within 6 months of screening) NYHA Class...
- 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...
See the full eligibility criteria
- Scheduled to undergo hemi thyroidectomy or total thyroidectomy for thyroid disease, including neoplasm
- Must be a minimum of 18 years old or older
- Must be able to give documented informed consent to participate in this study
- Must be a surgical candidate according to standard of care practices, as determined by the clinical judgement of the investigator
- Sexually active fertile people and their partners must agree to use highly effective methods of contraception prior to study entry and during the course of the study.
- Female people of childbearing potential must not be pregnant or breastfeeding at screening. Female people are considered to be of childbearing potential unless one of the following criteria is met: o Permanent...
- Willing and able to comply with all study procedures
- Previous history of surgery and/or radiation to the head, neck, or shoulder
- Abnormal cardiac rhythm not controlled with medication
- The patient has a history of drug-related anaphylactic or severe allergic reactions (CTCAE grade 3+), at the discretion of the treating investigator
- Presence or history of any hypersensitivity to bevonescein (or fluorescein) 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 (MI) or cerebrovascular...
- 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
- Use of any Investigational Product or investigational medical device within 30 days prior to surgery date, or requirement for any investigational agent prior to completion of all scheduled study assessments
- The subject has current evidence of renal disease defined as glomerular filtration rate (GFR) \< 60 mL/min/1.73 m2
The study team makes the final eligibility decision.
Where it is enrolling
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.