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　　據(jù)最近在線出版在《臨床腫瘤學(xué)雜志》（Journal of Clinical Oncology）上的一項研究結(jié)果表明：哥倫比亞大學(xué)的Chaitanya R. Divgi等人通過碘-124（124I）吉瑞昔單抗標(biāo)記，行PET/CT可精確地以非侵入方式鑒定腎透明細(xì)胞癌（ccRCC）。該研究是世界上首個針對惡性腫瘤臨床驗證試驗：用生物標(biāo)記物分子標(biāo)記，通過正電子發(fā)射斷層掃描或計算機(jī)斷層掃描（PET/CT）成像的方法對腎癌細(xì)胞特征進(jìn)行研究。

　　該項研究是一項開放性多中心試驗，對預(yù)切除腎臟腫瘤患者應(yīng)用124I吉瑞昔單抗標(biāo)記，再行 PET/CT的情況進(jìn)行觀察。靜脈注射124I吉瑞昔單抗2～6天，在腎臟腫瘤切除前，研究人員通過PET/CT以及對比增強(qiáng)CT（CECT）方法對患者腹部進(jìn)行探查。所獲取的每幅圖像均由三位不知情判讀人員按各自的顯像方式進(jìn)行集中解讀。由一位不知情的病理學(xué)家對腫瘤切片進(jìn)行集中判定。研究對結(jié)果，即兩種顯像方式對腎透明細(xì)胞癌的敏感度與特異性進(jìn)行對比，對診斷者之間以及診斷者本人結(jié)果的一致性進(jìn)行評價。

　　研究結(jié)果表明：患者對124I吉瑞昔單抗的耐受性良好。研究共獲得195例患者的完整數(shù)據(jù)集（組織病理學(xué)診斷和PET/CT 與CECT結(jié)果）。PET/CT的平均敏感度為86.2%（95%CI=75.3%～97.1%），CECT為75.5%（95%CI=62.6%～88.4%；P=0.023）。PET/CT的平均特異性為85.9% （95%CI=69.4%～99.9%），CECT為46.8%（95%CI=18.8%～74.7%；P=0.005）。判讀者間一致性較高（κ范圍，PET/CT：0.87～0.92；CECT：0.67～0.76)，同樣，判讀者內(nèi)部一致性也較高（范圍，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.
文章來源：http://www.ncbi.nlm.nih.gov/pubmed/23213092