[123I]FP-CIT (DaTscan; Ioflupane I123 Injection) SPECT brain imaging - Diagnostic effectiveness in patients with movement disorders and/or dementia

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