| 嵇建峰,褚嘉栋,易贺庆.［89Zr］Zr-Girentuximab用于PET/CT成像辅助诊断透明细胞肾细胞癌的价值：ZIRCON研究解读[J].肿瘤学杂志,2025,31(5):455-460. |
| ［89Zr］Zr-Girentuximab用于PET/CT成像辅助诊断透明细胞肾细胞癌的价值：ZIRCON研究解读 |
| Assessing the Adjuvant Diagnosis Value of ［89Zr］Zr-Girentuximab for PET/CT Imaging of Clear-Cell Renal Cell Carcinoma： Interpretation of ZIRCON Study |
| 投稿时间：2025-03-19 |
| DOI：10.11735/j.issn.1671-170X.2025.05.B012 |
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| 中文关键词: Girentuximab 锆-89 正电子发射断层扫描/计算机断层扫描 透明细胞肾细胞癌 |
| 英文关键词:Girentuximab Zirconium-89 positron emission tomography/computed tomography clear-cell renal cell carcinoma |
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| 中文摘要: |
| 摘 要：由于传统影像学和活检的局限性，开发在肾肿块患者中更加准确、无创地检测透明细胞肾细胞癌技术仍然是一个迫切的需求。本次解读的Ⅲ期、开放标签、ZIRCON研究旨在评估［89Zr］Zr-Girentuximab PET/CT成像在辅助诊断透明细胞肾细胞癌方面的价值。2019年8月至2022年7月，该研究共纳入来自36个研究中心的符合入组标准的332例患者，其中300例接受［89Zr］Zr-Girentuximab PET/CT 检查。关键入组标准：①年龄≥18岁；②存在单个、局部不确定的、最大径≤7 cm的肾脏肿块（怀疑为透明细胞肾细胞癌）；③计划行肾切除术；④适于接受［89Zr］Zr-Girentuximab PET/CT成像。共同主要终点为［89Zr］Zr-Girentuximab PET/CT成像辅助诊断透明细胞肾细胞癌的灵敏度和特异度，次要终点包括在≤4 cm不确定性肾肿块亚组中的灵敏度和特异度等。该试验已在Clini-calTrials.gov注册（NCT03849118）。主要分析中共纳入284例可评估的患者，结果显示：①平均灵敏度为85.5%（95%CI：81.5%~89.6%），平均特异度为87.0%（95%CI：81.0%~93.1%）；②在261起不良事件中，有13起不良事件确定或者可能与［89Zr］Zr-Girentuximab相关；52起严重不良事件中，只有1起可能与［89Zr］Zr-Girentuximab相关。ZIRCON研究结果提示基于［89Zr］Zr-Girentuximab的PET/CT成像具有良好的安全性，是一种高度准确、无创的透明细胞肾细胞癌检测和表征的成像方式。 |
| 英文摘要: |
| Abstract： With limitations of conventional imaging and biopsy， more accurate and non-invasive techniques are needed for detecting clear-cell renal cell carcinoma(ccRCC) in patients with renal masses. The ZIRCON study， an open-label phase Ⅲ trial， was aimed to evaluate the adjuvant diagnosis value of ［89Zr］Zr-Girentuximab for PET/CT imaging of ccRCC. Between Aug， 2019 and July， 2022， a total of 332 patients from 36 centres， who met the inclusion criteria were enrolled， and 300 patients received ［89Zr］Zr-Girentuximab. Key inclusion criteria： ① Age ≥18 years old； ② Evidence of a single， localised indeterminate renal mass ≤7 cm in the largest diameter that was suspicious for ccRCC； ③ Planned nephrectomy； ④ Suitable ［89Zr］Zr-Girentuximab for PET/CT imaging. Co-primary endpoints were sensitivity and specificity of ［89Zr］Zr-Girentuximab for PET/CT imaging of ccRCC. Secondary endpoints included sensitivity and specificity in a subgroup of ≤4 cm indeterminate renal masses and so on. The trial was registered with ClinicalTrials.gov (NCT03849118). A total of 284 evaluable patients were included in the primary analysis. The results showed that： ① The average sensitivity was 85.5% (95%CI： 81.5%~89.6%)， and the average specificity was 87.0% (95%CI： 81.0% ~93.1%)； ② Of the 261 adverse events， 13 were considered possibly or definitely related to ［89Zr］Zr-Girentuximab， and of the 52 serious adverse events， only one was considered possibly related to ［89Zr］Zr-Girentuximab. The results of the ZIRCON study suggested that ［89Zr］Zr-Girentuximab for PET/CT imaging might be an effective and safe way to detect ccRCC accurately and non-invasively. |
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