%0 Journal Article %A Klaus Tatsch %A Igor Grachev %A John O’Brien %A Ian McKeith %A Zuzana Walker %A Eduardo Tolosa %A Paul Sherwin %A Wolfgang Oertel %A Donald Grosset %T [123I]FP-CIT (DaTscan; Ioflupane I123 Injection) SPECT brain imaging - Diagnostic effectiveness in patients with movement disorders and/or dementia %D 2014 %J Journal of Nuclear Medicine %P 305-305 %V 55 %N supplement 1 %X 305 Objectives Early and accurate diagnosis of movement disorders and dementia is critical to ensuring optimal clinical management. To better estimate the diagnostic performance of [123I]FP-CIT, we conducted a pooled analysis of four clinical trials. Methods Four trials (including two primary) that were submitted in support of approval of [123I]FP-CIT in the USA were pooled to determine the overall sensitivity and specificity of [123I]FP-CIT images in detecting or excluding a striatal dopaminergic deficit, which is associated with Parkinsonian syndromes and DLB. Patients with either a movement disorder or dementia, and healthy volunteers were administered [123I]FP-CIT. Images were assessed by panels of 3-5 blinded experts and/or on-site nuclear medicine physicians, classified as normal or abnormal, and compared with expert (panel used in 2 of the 4 studies) clinical diagnosis to determine sensitivity and specificity. Results Pooling the 4 studies, 928 subjects were enrolled, 849 were dosed, and 764 completed their respective study. Across all studies when images were assessed by on-site readers, [123I]FP-CIT diagnostic effectiveness had an overall (95% CI) sensitivity of 91.9% and specificity of 83.6%. When reads were conducted blindly by a panel of independent experts, the overall sensitivity was 88.7% and specificity was 91.2%. For subjects with PS vs. ET and DLB vs. AD, the sensitivity and specificity was similar. Conclusions In this pooled analysis, the visual assessment of [123I]FP-CIT images provided high levels of sensitivity and specificity. [123I]FP-CIT imaging has the potential to improve diagnostic accuracy in patients with signs and symptoms of a movement disorder and/or dementia. Research Support GE Healthcare %U