title: Reader Training for the Restaging of Biochemically Recurrent Prostate Cancer Using18F-Fluciclovine PET/CT.
abstract: 18F-Fluciclovine is a novel PET/CT tracer. This blinded image evaluation (BIE) sought to demonstrate that, after limited training, readers naïve to18F-fluciclovine could interpret18F-fluciclovine images from subjects with biochemically recurrent prostate cancer with acceptable diagnostic performance and reproducibility. The primary objectives were to establish individual readers' diagnostic performance and the overall interpretation (2/3 reader concordance) compared with standard-of-truth data (histopathology or clinical follow-up) and to evaluate interreader reproducibility. Secondary objectives included comparison to the expert reader and assessment of intrareader reproducibility.Methods:18F-Fluciclovine PET/CT images (n= 121) and corresponding standard-of-truth data were collected from 110 subjects at Emory University using a single-time-point static acquisition starting 5 min after injection of approximately 370 MBq of18F-fluciclovine. Three readers were trained using standardized interpretation methodology and subsequently evaluated the images in a blinded manner. Analyses were conducted at the lesion, region (prostate, including bed and seminal vesicle, or extraprostatic, including all lymph nodes, bone, or soft-tissue metastasis), and subject level.Results:Lesion-level overall positive predictive value was 70.5%. The readers' positive predictive value and negative predictive value were broadly consistent with each other and with the onsite read. Sensitivity was highest for readers 1 and 2 (68.5% and 63.9%, respectively) whereas specificity was highest for reader 3 (83.6%). Overall, prostate-level sensitivity was high (91.4%), but specificity was moderate (48.7%). Interreader agreement was 94.7%, 74.4%, and 70.3% for the lesion, prostate, and extraprostatic levels, respectively, with associated Fleiss' κ-values of 0.54, 0.50, and 0.57. Intrareader agreement was 97.8%, 96.9%, and 99.1% at the lesion level; 100%, 100%, and 91.7% in the prostate region; and 83.3%, 75.0%, and 83.3% in the extraprostatic region for readers 1, 2, and 3, respectively. Concordance between the BIE and the onsite reader exceeded 75% for each reader at the lesion, region, and subject levels.Conclusion:Specific training in the use of standardized interpretation methodology for assessment of18F-fluciclovine PET/CT images enables naïve readers to achieve acceptable diagnostic performance and reproducibility when staging recurrent prostate cancer.
authors.affiliation: Blue Earth Diagnostics (BED), Oxford, United Kingdom m.miller@blueearthdx.com.
authors.forename: Matthew P
authors.initials: MP
authors.lastname: Miller
authors.affiliation: Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Lale
authors.initials: L
authors.lastname: Kostakoglu
authors.affiliation: Department of Radiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.
authors.forename: Daniel
authors.initials: D
authors.lastname: Pryma
authors.affiliation: Fox Chase Cancer Center, Philadelphia, Pennsylvania.
authors.forename: Jian Qin
authors.initials: JQ
authors.lastname: Yu
authors.affiliation: Blue Earth Diagnostics (BED), Oxford, United Kingdom.
authors.forename: Albert
authors.initials: A
authors.lastname: Chau
authors.affiliation: American College of Radiology, Philadelphia, Pennsylvania; and.
authors.forename: Eric
authors.initials: E
authors.lastname: Perlman
authors.affiliation: Society of Nuclear Medicine and Molecular Imaging Clinical Trials Network, Reston, Virginia.
authors.forename: Bonnie
authors.initials: B
authors.lastname: Clarke
authors.affiliation: American College of Radiology, Philadelphia, Pennsylvania; and.
authors.forename: Donald
authors.initials: D
authors.lastname: Rosen
authors.affiliation: Blue Earth Diagnostics (BED), Oxford, United Kingdom.
authors.forename: Penelope
authors.initials: P
authors.lastname: Ward
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002264:Carboxylic Acids; D003503:Cyclobutanes; D005260:Female; D006801:Humans; D007090:Image Interpretation, Computer-Assisted / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D015588:Observer Variation; D000072078:Positron Emission Tomography Computed Tomography; D011471:Prostatic Neoplasms / Q000000981:diagnostic imaging* / Q000378:metabolism / Q000473:pathology*; D012008:Recurrence
chemical_list: D002264:Carboxylic Acids; D003503:Cyclobutanes; C117460:fluciclovine F-18
keywords: 18F-FACBC; 18F-Fluciclovine; PET/CT; prostate cancer