据最近在线出版在《临床肿瘤学杂志》（Journal of Clinical Oncology）上的一项研究结果表明：哥伦比亚大学的Chaitanya R. Divgi等人通过碘-124（124I）吉瑞昔单抗标记，行PET/CT可精确地以非侵入方式鉴定肾透明细胞癌（ccRCC）。该研究是世界上首个针对恶性肿瘤临床验证试验：用生物标记物分子标记，通过正电子发射断层扫描或计算机断层扫描（PET/CT）成像的方法对肾癌细胞特征进行研究。

　　该项研究是一项开放性多中心试验，对预切除肾脏肿瘤患者应用124I吉瑞昔单抗标记，再行 PET/CT的情况进行观察。静脉注射124I吉瑞昔单抗2～6天，在肾脏肿瘤切除前，研究人员通过PET/CT以及对比增强CT（CECT）方法对患者腹部进行探查。所获取的每幅图像均由三位不知情判读人员按各自的显像方式进行集中解读。由一位不知情的病理学家对肿瘤切片进行集中判定。研究对结果，即两种显像方式对肾透明细胞癌的敏感度与特异性进行对比，对诊断者之间以及诊断者本人结果的一致性进行评价。

　　研究结果表明：患者对124I吉瑞昔单抗的耐受性良好。研究共获得195例患者的完整数据集（组织病理学诊断和PET/CT 与CECT结果）。PET/CT的平均敏感度为86.2%（95%CI=75.3%～97.1%），CECT为75.5%（95%CI=62.6%～88.4%；P=0.023）。PET/CT的平均特异性为85.9% （95%CI=69.4%～99.9%），CECT为46.8%（95%CI=18.8%～74.7%；P=0.005）。判读者间一致性较高（κ范围，PET/CT：0.87～0.92；CECT：0.67～0.76)，同样，判读者内部一致性也较高（范围，PET/CT：87%～100% ；CECT：73.7%～91.3%）。

　　Positron Emission Tomography/Computed Tomography Identification of Clear Cell Renal Cell Carcinoma: Results From the REDECT Trial

　　Purpose

　　A clinical study to characterize renal masses with positron emission tomography/computed tomography (PET/CT) was undertaken.

　　Patients And methods

　　This was an open-label multicenter study of iodine-124 (124I) -girentuximab PET/CT in patients with renal masses who were scheduled for resection. PET/CT and contrast-enhanced CT (CECT) of the abdomen were performed 2 to 6 days after intravenous 124I-girentuximab administration and before resection of the renal mass(es). Images were interpreted centrally by three blinded readers for each imaging modality. Tumor histology was determined by a blinded central pathologist. The primary end points—average sensitivity and specificity for clear cell renal cell carcinoma (ccRCC)—were compared between the two modalities. Agreement between and within readers was assessed.

　　Results

　　124I-girentuximab was well tolerated. In all, 195 patients had complete data sets (histopathologic diagnosis and PET/CT and CECT results) available. The average sensitivity was 86.2% (95% CI, 75.3% to 97.1%) for PET/CT and 75.5% (95% CI, 62.6% to 88.4%) for CECT (P = .023). The average specificity was 85.9% (95% CI, 69.4% to 99.9%) for PET/CT and 46.8% (95% CI, 18.8% to 74.7%) for CECT (P = .005). Inter-reader agreement was high (κ range, 0.87 to 0.92 for PET/CT; 0.67 to 0.76 for CECT), as was intrareader agreement (range, 87% to 100% for PET/CT; 73.7% to 91.3% for CECT).

　　Conclusion

　　This study represents (to the best of our knowledge) the first clinical validation of a molecular imaging biomarker for malignancy. 124I-girentuximab PET/CT can accurately and noninvasively identify ccRCC, with potential utility for designing best management approaches for patients with renal masses.
文章来源：http://www.ncbi.nlm.nih.gov/pubmed/23213092