Bevonescein for Improved Intraoperative Nerve Visualization to Improve Voice Outcomes in Thyroidectomy Patients
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMatthew Spector
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Bevonescein (ALM 488) Infusion
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Matthew Spector
Lead sponsor
University of Pittsburgh
Sponsor institution
Alume Biosciences, Inc.
Collaborator
Source ClinicalTrials.gov