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Intraoperative nerve-specific fluorescence visualization in head and neck surgery: a Phase 1 trial
Yu-Jin Lee1, Ryan K Orosco2, Michael Bouvet3
1Department of Otolaryngology-Head and Neck Surgery, Stanford University, Palo Alto, CA, USA.
Nature Communications
|July 2, 2025
Summary
Bevonescein, a novel nerve imaging agent, was safely administered intravenously in a Phase 1 trial for head and neck surgeries. The study found it well-tolerated, identifying an optimal dose for improved nerve visualization during procedures.
Area of Science:
- Surgical oncology
- Pharmacology
- Medical imaging
Background:
- Iatrogenic nerve injury is a significant surgical complication.
- Bevonescein is a systemic agent designed to selectively bind to nerves.
- Head and neck surgeries like parotidectomy and thyroidectomy carry risks of nerve damage.
Purpose of the Study:
- To evaluate the safety and tolerability of systemically administered bevonescein.
- To determine the optimal dose, pharmacokinetics, and timing of bevonescein for nerve imaging.
- To assess the efficacy of bevonescein in enhancing nerve visualization compared to standard methods.
Main Methods:
- A single-arm, prospective, multi-center, dose-escalation Phase 1 clinical trial.
- 27 adult patients undergoing parotidectomy or thyroidectomy received systemic bevonescein.
- Safety outcomes included dose-limiting toxicity and adverse events; secondary outcomes focused on pharmacokinetics and imaging quality (SBR).
Main Results:
- Bevonescein was well-tolerated with no dose-limiting toxicity observed.
- A single adverse event (vomiting) was possibly related to the drug.
- The optimal dose was determined to be 500 mg, with significantly higher nerve signal-to-background ratio (SBR) compared to white light (p=0.003).
- Half-life ranged from 29-72 minutes; no significant difference in SBR was found between early and late timing cohorts.
Conclusions:
- Preoperative intravenous infusion of bevonescein is safe and well-tolerated in patients undergoing head and neck surgery.
- Bevonescein demonstrates potential as a valuable nerve imaging agent, improving intraoperative nerve identification.
- Further investigation into optimal timing and broader clinical application is warranted.
