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Updated: Sep 8, 2025

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Rizedisben in Minimally Invasive Surgery: A Nonrandomized Clinical Trial.

Samuel A Gold1, Maria M Pere1, Melissa Assel2

  • 1Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.

JAMA Surgery
|July 2, 2025
PubMed

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Summary
This summary is machine-generated.

Rizedisben effectively illuminates nerves during surgery. The 3.0 mg/kg dose demonstrated sustained fluorescence and was well-tolerated in this phase 1 trial, paving the way for further studies.

Area of Science:

  • Surgical Navigation
  • Medical Imaging
  • Pharmacology

Background:

  • Fluorescence-guided surgery enhances intraoperative visualization of critical structures.
  • Rizedisben is a novel myelin-binding fluorophore designed for improved intraoperative nerve identification using blue light (370-425 nm).

Purpose of the Study:

  • To establish the optimal, safe, and clinically effective dose of rizedisben for sustained intraoperative fluorescence of nerve structures.
  • To evaluate the safety and efficacy of rizedisben in patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP).

Main Methods:

  • A single-arm, open-label, phase 1 dose-escalation study was conducted in 38 patients undergoing RALP.
  • Rizedisben was administered intravenously 30 minutes prior to nerve visualization, with doses escalating from 0.25 to 3.0 mg/kg.

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  • Safety was monitored for 45 days post-surgery, and fluorescence intensity was assessed intraoperatively and via post hoc image analysis.

    • Main Results:

    • The 3.0 mg/kg dose of rizedisben achieved sustained obturator nerve fluorescence in all patients.
    • Excellent sustained fluorescence (moderate or better for ≥90 minutes) was observed at the 3.0 mg/kg dose.
    • Prostate neurovascular bundles showed fluorescence in 89% of patients at the 3.0 mg/kg dose, with only one possibly related grade 2 adverse event (rash).

    Conclusions:

    • The 3.0 mg/kg dose of rizedisben is well-tolerated and clinically effective for intraoperative nerve visualization.
    • Sustained fluorescence of the obturator nerve and visualization of neurovascular bundles were successfully achieved.
    • Phase 2 studies are planned to explore rizedisben for additional indications, building on these promising phase 1 results.