Bevonescein for Improved Intraoperative Nerve Visualization to Improve Voice Outcomes in Thyroidectomy Patients
Part of paid clinical trials in Pittsburgh, Pennsylvania.
- Sponsor
- Matthew Spector
- Study ID
- NCT07631650
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Head and Neck Cancer
- Head and Neck Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bevonescein (ALM 488) Infusion — DRUGBevonescein is a synthetic peptide of 17 amino acids conjugated to a fluorescein derivative (5-carboxyfluorescein \[FAM\]) and can be visualized using instruments suitable for visualizing fluorescein. Bevonescein selectively binds to extracellular matrix of nerve tissue, increasing nerve visibility and enhancing structure delineation of nerve tissue, potentially reducing the time needed for surgeons to identify nerve tissue and reducing likelihood of nerve injury during thyroidectomy surgery.
Study Details
Bevonescein (ALM-488) is a novel fluorescein-containing peptide that is intended as a visualization adjunct for the real-time enhanced structural delineation of major nerves during Head and Neck surgery to potentially improve patient outcomes.
Key Dates
- Start date
- Jun 30, 2026
- Status verified
- Jun 2026
- Primary completion
- Aug 31, 2027
- Completion
- Aug 31, 2027
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Bevonescein (ALM 488) Infusion
Primary Outcome Measure
Change in Voice Handicap Index (VHI) scores [ Time Frame: At baseline (before surgery) and at 28 days post-surgery ]
Central Contacts
- Jennifer Ruth412-623-8963
- Mel J Mendez, BS, BS878-261-6071
Locations (1)
| Facility | City | State | ZIP |
|---|---|---|---|
| UMPC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 |
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