A Phase 2 Trial of Systemic Administration of Bevonescein for Improved Intraoperative Nerve Visualization to Improve Voice Outcomes in Patients Undergoing Thyroidectomy
Matthew Spector
Summary
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.
Description
Patients with thyroid disease undergoing thyroidectomy will receive systemic administration of bevonescein pre-operatively for intraoperative visualization of nerves. The voice outcomes of these patients will be assessed pre-operatively and post-operatively using patient questionnaires. This study aims to show that improved nerve visualization with bevonescein will be associated with clinically meaningful improvement in voice outcomes compared to a previously published studies.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Scheduled to undergo hemi thyroidectomy or total thyroidectomy for thyroid disease, including neoplasm 2. Must be a minimum of 18 years old or older 3. Must be able to give documented informed consent to participate in this study 4. Must be a surgical candidate according to standard of care practices, as determined by the clinical judgement of the investigator 5. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception prior to study entry and during the course of the study. An additional contraceptive method, such…
Interventions
- DrugBevonescein (ALM 488) Infusion
Bevonescein 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.
Location
- UMPC Hillman Cancer CenterPittsburgh, Pennsylvania