EconPapers    
Economics at your fingertips  
 

Intraoperative nerve-specific fluorescence visualization in head and neck surgery: a Phase 1 trial

Yu-Jin Lee, Ryan K. Orosco, Michael Bouvet, Jeremy D. Richmon, Brett J. Berman, Kayva L. Crawford, Marisa Hom, Quyen T. Nguyen and Eben L. Rosenthal ()
Additional contact information
Yu-Jin Lee: Stanford University
Ryan K. Orosco: University of New Mexico
Michael Bouvet: San Diego
Jeremy D. Richmon: Harvard Medical School
Brett J. Berman: Alume Biosciences
Kayva L. Crawford: San Diego
Marisa Hom: Vanderbilt University
Quyen T. Nguyen: Alume Biosciences
Eben L. Rosenthal: Vanderbilt University

Nature Communications, 2025, vol. 16, issue 1, 1-12

Abstract: Abstract Iatrogenic nerve injury is a surgical complication with significant morbidity. This clinical trial, now complete, investigates the systemic administration of bevonescein, which selectively binds to nerves, in a single-arm, prospective multi-center, dose-escalation Phase 1 trial in adult patients with head and neck neoplasms undergoing parotidectomy or thyroidectomy in the United States. Twenty-seven participants are enrolled in the trial and receive the systemic agent. The primary outcome is safety with no dose-limiting toxicity among the 27 patients, but a single adverse event was identified that was possibly related to the study drug (vomiting). Secondary outcomes include the pharmacokinetics, optimal dose, and timing of bevonescein. The half-life of bevonescein is 29–72 min, and the optimal dose is 500 mg by objective measures, with the fluorescence signal-to-background ratio (SBR; 2.1 ± 0.8) significantly higher compared to white light (1.3 ± 0.2; p = 0.003). The fluorescent SBR of nerves between the early (1–3 h) versus late (3–5 h) timing cohorts is not statistically different. Here, we present data of a nerve imaging agent showing that preoperative intravenous infusion of bevonescein is well tolerated. This trial is registered at ClinicalTrials.gov (NCT04420689) and is sponsored by Alume Biosciences (San Diego, CA).

Date: 2025
References: Add references at CitEc
Citations:

Downloads: (external link)
https://www.nature.com/articles/s41467-025-60737-x Abstract (text/html)

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:nat:natcom:v:16:y:2025:i:1:d:10.1038_s41467-025-60737-x

Ordering information: This journal article can be ordered from
https://www.nature.com/ncomms/

DOI: 10.1038/s41467-025-60737-x

Access Statistics for this article

Nature Communications is currently edited by Nathalie Le Bot, Enda Bergin and Fiona Gillespie

More articles in Nature Communications from Nature
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().

 
Page updated 2025-07-03
Handle: RePEc:nat:natcom:v:16:y:2025:i:1:d:10.1038_s41467-025-60737-x