Bevonescein for ENT Disorders
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called Bevonescein (also known as ALM-488), which helps surgeons see major nerves more clearly during head and neck surgeries. The goal is to improve surgical outcomes by reducing the risk of nerve damage. Individuals scheduled for thyroid surgery due to thyroid disease might be suitable candidates for this trial, especially those concerned about surgical complications. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that Bevonescein (ALM-488) is likely to be safe for humans?
Research has shown that bevonescein is generally safe for people. In earlier studies, patients who took bevonescein experienced no serious safety problems. For instance, one study found no safety issues when patients received up to 1000mg of bevonescein, which is twice the amount planned for use in surgeries. This indicates a good safety margin for the treatment. Additionally, early data from human studies supports its safety, with no major side effects reported. These findings suggest that bevonescein is generally safe for use in surgeries involving the head and neck.12345
Why do researchers think this study treatment might be promising?
Bevonescein (ALM-488) is unique because it uses a fluorescent dye to target and illuminate tissues in ENT (ear, nose, and throat) procedures. Unlike traditional treatments that only address symptoms or infections, Bevonescein helps surgeons visualize and differentiate tissues more clearly, potentially improving surgical precision. Researchers are excited about this treatment because it could reduce the risk of complications and improve outcomes in ENT surgeries by providing real-time, enhanced visibility of the surgical area.
What evidence suggests that Bevonescein might be an effective treatment for ENT disorders?
Research has shown that bevonescein, which participants in this trial will receive, can greatly enhance nerve visibility during head and neck surgeries. Studies found that it makes nerves more visible under fluorescent light compared to regular white light. Patients who received bevonescein did not experience any serious side effects, indicating its safety. This improved visibility could help surgeons avoid nerve damage, leading to better surgical outcomes.13456
Who Is on the Research Team?
Matthew E Spector
Principal Investigator
UPMC Hillman Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults (18+) scheduled for partial or total thyroid removal surgery due to thyroid disease, including cancer. Participants must be able to give consent, be suitable for surgery, and agree to use effective birth control if they are fertile.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Assessment
Participants undergo pre-operative assessment including baseline Voice Handicap Index (VHI) scoring
Surgery and Treatment
Systemic administration of bevonescein for intraoperative nerve visualization during thyroidectomy
Post-operative Follow-up
Participants are monitored for voice outcomes using VHI scores at 28 days post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- Bevonescein (ALM-488)
Trial Overview
The study tests Bevonescein (ALM-488), a special dye given by infusion during thyroid surgery. It helps surgeons see nerves more clearly in real time, aiming to reduce nerve injury and improve voice outcomes after the operation.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Matthew Spector
Lead Sponsor
Alume Biosciences, Inc.
Industry Sponsor
Citations
1.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT06227585/feasibility-study-for-bevonescein-assisted-nerve-visualization-in-head-neck-surgeryFeasibility and Efficacy Study for Bevonescein-Assisted ...
A Part 1 Phase 2 feasibility study to characterize the feasibility of using the REVEAL 475 system by obtaining surgeon perspective on ...
NCT05377554 | Bevonescein for Intra-Operative Nerve ...
This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate bevonescein.
Intraoperative nerve-specific fluorescence visualization in ...
Here, we present data of a nerve imaging agent showing that preoperative intravenous infusion of bevonescein is well tolerated.
Alume Biosciences Announces Publication of Data ...
Bevonescein provided enhanced nerve visualization with higher nerve conspicuity scores in fluorescent compared to white light. All participants ...
Groundbreaking Research Advances Patient Care Across ...
These discoveries will inform clinical practice guidelines, shape future research directions, and ultimately improve outcomes for patients with ...
Bevonescein for ENT Disorders · Info for Participants
Prior Safety DataThis treatment has passed at least one previous human trial. What You Need to Know Before You Apply. What is the purpose of ...
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