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

American Society of Clinical Oncology (ASCO) - Tập 31 Số 2 - Trang 187-194 - 2013
Chaitanya Divgi1, Robert G. Uzzo1, Constantine Gatsonis1, Roman Bartz1, Silke Treutner1, Jian Q. Yu1, Ying‐Bei Chen1, Jorge A. Carrasquillo1, Steven M. Larson1, Paul Bevan1, Paul Russo1
1Chaitanya R. Divgi, Columbia University; Jorge A. Carrasquillo, Steven Larson, and Paul Russo, Memorial Sloan-Kettering Cancer Center, New York, NY; Robert G. Uzzo, Jian Qin Yu, and David Chen, Fox Chase Cancer Center, Philadelphia, PA; Constantine Gatsonis, Brown University, Providence, RI; Roman Bartz, Silke Treutner, and Paul Bevan, Wilex, Munich, Germany.

Tóm tắt

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.

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American Society of Clinical Oncology (ASCO)

Tập 31 Số 2

187-194

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