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<p>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; <i>p</i> = 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).</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月2日

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  • Yu-Jin Lee,
  • Ryan K. Orosco,
  • Michael Bouvet,
  • Jeremy D. Richmon,
  • Brett J. Berman,
  • Kayva L. Crawford,
  • Marisa Hom,
  • Quyen T. Nguyen,
  • Eben L. Rosenthal

摘要

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).