title: Positron emission tomography/computed tomography identification of clear cell renal cell carcinoma: results from the REDECT trial.
abstract: A clinical study to characterize renal masses with positron emission tomography/computed tomography (PET/CT) was undertaken.
  
  
  
  This was an open-label multicenter study of iodine-124 ((124)I) -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 (124)I-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.
  
  
  
  (124)I-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).
  
  
  
  This study represents (to the best of our knowledge) the first clinical validation of a molecular imaging biomarker for malignancy. (124)I-girentuximab PET/CT can accurately and noninvasively identify ccRCC, with potential utility for designing best management approaches for patients with renal masses.
authors.affiliation: Columbia University, New York, NY 10032, USA. crdivgi@columbia.edu
authors.forename: Chaitanya R
authors.initials: CR
authors.lastname: Divgi
authors.forename: Robert G
authors.initials: RG
authors.lastname: Uzzo
authors.forename: Constantine
authors.initials: C
authors.lastname: Gatsonis
authors.forename: Roman
authors.initials: R
authors.lastname: Bartz
authors.forename: Silke
authors.initials: S
authors.lastname: Treutner
authors.forename: Jian Qin
authors.initials: JQ
authors.lastname: Yu
authors.forename: David
authors.initials: D
authors.lastname: Chen
authors.forename: Jorge A
authors.initials: JA
authors.lastname: Carrasquillo
authors.forename: Steven
authors.initials: S
authors.lastname: Larson
authors.forename: Paul
authors.initials: P
authors.lastname: Bevan
authors.forename: Paul
authors.initials: P
authors.lastname: Russo
mesh_terms: D000911:Antibodies, Monoclonal; D002292:Carcinoma, Renal Cell / Q000175:diagnosis* / Q000000981:diagnostic imaging* / Q000473:pathology; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007457:Iodine Radioisotopes; D007680:Kidney Neoplasms / Q000175:diagnosis* / Q000000981:diagnostic imaging* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D064847:Multimodal Imaging / Q000379:methods; D049268:Positron-Emission Tomography; D019275:Radiopharmaceuticals; D014057:Tomography, X-Ray Computed
chemical_list: C581012:124I-girentuximab; D000911:Antibodies, Monoclonal; D007457:Iodine Radioisotopes; D019275:Radiopharmaceuticals