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Clinical Trial, Phase III
Clinical Trial, Phase IV
Journal Article
Multicenter Study
Diagnostic Performance of the Visual Reading of 123 I-Ioflupane SPECT Images With or Without Quantification in Patients With Movement Disorders or Dementia.
Journal of Nuclear Medicine 2017 November
Visual interpretation of123 I-ioflupane SPECT images has high diagnostic accuracy for differentiating parkinsonian syndromes (PS), from essential tremor and probable dementia with Lewy bodies (DLB) from Alzheimer disease. In this study, we investigated the impact on accuracy and reader confidence offered by the addition of image quantification in comparison with visual interpretation alone. Methods: We collected 304123 I-ioflupane images from 3 trials that included subjects with a clinical diagnosis of PS, non-PS (mainly essential tremor), probable DLB, and non-DLB (mainly Alzheimer disease). Images were reconstructed with standardized parameters before striatal binding ratios were quantified against a normal database. Images were assessed by 5 nuclear medicine physicians who had limited prior experience with123 I-ioflupane interpretation. In 2 readings at least 1 mo apart, readers performed either a visual interpretation alone or a combined reading (i.e., visual plus quantitative data were available). Readers were asked to rate their confidence of image interpretation and judge scans as easy or difficult to read. Diagnostic accuracy was assessed by comparing image results with the standard of truth (i.e., diagnosis at follow-up) by measuring the positive percentage of agreement (equivalent to sensitivity) and the negative percentage of agreement (equivalent to specificity). The hypothesis that the results of the combined reading were not inferior to the results of the visual reading analysis was tested. Results: A comparison of the combined reading and the visual reading revealed a small, insignificant increase in the mean negative percentage of agreement (89.9% vs. 87.9%) and equivalent positive percentages of agreement (80.2% vs. 80.1%). Readers who initially performed a combined analysis had significantly greater accuracy (85.8% vs. 79.2%; P = 0.018), and their accuracy was close to that of the expert readers in the original studies (range, 83.3%-87.2%). Mean reader confidence in the interpretation of images showed a significant improvement when combined analysis was used ( P < 0.0001). Conclusion: The addition of quantification allowed readers with limited experience in the interpretation of123 I-ioflupane SPECT scans to have diagnostic accuracy equivalent to that of the experienced readers in the initial studies. Also, the results of the combined reading were not inferior to the results of the visual reading analysis and offered an increase in reader confidence.
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