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| 评估[89Zr]Zr-girentuximab用于PET-CT成像辅助诊断透明细胞肾癌的价值：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 the ZIRCON study |
| 投稿时间：2025-03-19 修订日期：2025-04-19 |
| DOI： |
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| 中文关键词: 吉妥昔单抗 透明细胞肾癌 锆-89 |
| 英文关键词:Girentuximab RCC Zirconium-89 |
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| 中文摘要: |
| 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[??Zr]Zr-girentuximab PET-CT成像在辅助诊断透明细胞肾癌方面的价值。
2019年8月至2022年7月，该研究共纳入来自36家中心的、符合入组标准的332例患者，其中300例接受[??Zr]Zr-girentuximab治疗。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≤7cm的肾脏肿块（怀疑为透明细胞肾癌）；③计划行肾切除术；④适于接受[??Zr]Zr-girentuximab PET-CT成像。共同主要终点为[??Zr]Zr-girentuximab PET-CT成像辅助诊断透明细胞肾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ClinicalTrials.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%（95%CI：81% - 93.1%）；2）没有观察到与[??Zr]Zr-girentuximab相关的安全性事件；3）最常见的≥3级不良事件包括手术后出血（6/261,2%）、尿潴留（3/261,1%）和高血压（3/261,1%）。
因此，ZIRCON研究结果提示基于[??Zr]Zr-girentuximab的PET-CT成像具有良好的安全性，是一种高度准确、无创的透明细胞肾癌检测和表征的成像方式。 |
| 英文摘要: |
| With limitations of conventional imaging and biopsy, more accurate and non-invasive techniques to detect clear cell renal cell carcinoma in patients with renal masses remains an urgent need. 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 clear-cell renal cell carcinoma. Between Aug 14, 2019 and July 8, 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: i) age 18 years or older; ii) evidence of a single, localised indeterminate renal mass ≤7 cm in the largest diameter that was suspicious for clear-cell renal cell carcinoma; iii) planned nephrectomy; iv) suitable [89Zr]Zr-girentuximab for PET-CT imaging. Co-primary endpoints were sensitivity and specificity of [89Zr]Zr-girentuximab for PET-CT imaging of clear cell renal carcinoma. Secondary endpoints included sensitivity and specificity in a subgroup of ≤4 cm indeterminate renal masses and so on. The trial is registered with ClinicalTrials.gov (NCT03849118). A total of 284 evaluable patients were included in the primary analysis, and results showed that: i) The average sensitivity was 85.5% (95% CI: 81.5 - 89.6), and the average specificity was 87% (95% CI: 81% - 93.1%); ii) No safety events were observed that related to [89Zr]Zr-girentuximab; iii) The most common grade ≥3 adverse events were post-procedural haemorrhage (6/261,2%), urinary retention (3/261,1%), and hypertension (3/261,1%). Thus, the results of the ZIRCON study suggested that [89Zr]Zr-girentuximab for PET-CT imaging might be a great and safety way to detect clear-cell renal cell carcinoma accurately and non-invasively. |
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