Positron emission tomography/computed tomography identification of clear cell renal cell carcinoma: Results from the REDECT trial

Chaitanya R. Divgi, Robert G. Uzzo, Constantine Gatsonis, Roman Bartz, Silke Treutner, Jian Qin Yu, David Chen, Jorge A. Carrasquillo, Steven Larson, Paul Bevan, Paul Russo

Research output: Contribution to journalArticlepeer-review

197 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)187-194
Number of pages8
JournalJournal of Clinical Oncology
Volume31
Issue number2
DOIs
StatePublished - Jan 10 2013

Keywords

  • Antibodies, Monoclonal
  • Carcinoma, Renal Cell/diagnosis
  • Cohort Studies
  • Female
  • Humans
  • Iodine Radioisotopes
  • Kidney Neoplasms/diagnosis
  • Male
  • Middle Aged
  • Multimodal Imaging/methods
  • Positron-Emission Tomography
  • Radiopharmaceuticals
  • Tomography, X-Ray Computed

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