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<p>In oral squamous cell carcinoma (OSCC) surgery, inadequate tumor margins are reported in up to 85% of cases, adversely affecting outcomes. In this prospective, single-center study (n = 31; NCT04191460), we evaluated the safety and imaging feasibility of cRGD-ZW800-1, a near-infrared fluorescent integrin-targeted tracer. The secondary objective was to determine whether intraoperative fluorescence imaging could identify inadequate resection margins and inform surgical decision-making. Patients received 0.01, 0.025, or 0.05 mg/kg cRGD-ZW800-1, and tracer uptake was quantified using in vivo multi-diameter single-fiber reflectance and single-fiber fluorescence spectroscopy to optimize dosing and timing. All doses were well tolerated, achieving tumor-to-background ratios exceeding 4.5, with optimal performance at 0.025 mg/kg. Fluorescence imaging detected all 23 inadequate margins, including nine undetected by conventional assessment (sensitivity 100% versus 70%), altered surgical plans in five cases, and avoided adjuvant radiotherapy in three cases. These findings demonstrate that cRGD-ZW800-1 is safe, tumor-specific, and facilitates intraoperative margin assessment in OSCC.</p>

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Near-infrared fluorescence imaging-guided surgery using cRGD-ZW800 to improve surgical resection margins in oral cancer: a phase I/II feasibility trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月22日

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  • B. E. Zweedijk,
  • L. J. Lauwerends,
  • H. A. Galema,
  • D. J. Robinson,
  • H. S. de Bruijn,
  • H. Abbasi,
  • T. L. March,
  • A. R. P. M. Valentijn,
  • M. Pool,
  • H. Mast,
  • B. P. Jonker,
  • J. A. U. Hardillo,
  • D. Monserez,
  • A. Sewnaik,
  • S. Koljenovic,
  • C. Verhoef,
  • R. J. Baatenburg de Jong,
  • J. V. Frangioni,
  • S. A. Koppes,
  • D. E. Hilling,
  • A. L. Vahrmeijer,
  • S. Keereweer

摘要

In oral squamous cell carcinoma (OSCC) surgery, inadequate tumor margins are reported in up to 85% of cases, adversely affecting outcomes. In this prospective, single-center study (n = 31; NCT04191460), we evaluated the safety and imaging feasibility of cRGD-ZW800-1, a near-infrared fluorescent integrin-targeted tracer. The secondary objective was to determine whether intraoperative fluorescence imaging could identify inadequate resection margins and inform surgical decision-making. Patients received 0.01, 0.025, or 0.05 mg/kg cRGD-ZW800-1, and tracer uptake was quantified using in vivo multi-diameter single-fiber reflectance and single-fiber fluorescence spectroscopy to optimize dosing and timing. All doses were well tolerated, achieving tumor-to-background ratios exceeding 4.5, with optimal performance at 0.025 mg/kg. Fluorescence imaging detected all 23 inadequate margins, including nine undetected by conventional assessment (sensitivity 100% versus 70%), altered surgical plans in five cases, and avoided adjuvant radiotherapy in three cases. These findings demonstrate that cRGD-ZW800-1 is safe, tumor-specific, and facilitates intraoperative margin assessment in OSCC.