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Is ioflupane I123 injection diagnostically effective in patients with movement disorders and dementia? Pooled analysis of four clinical trials

Lookup NU author(s): Professor John O'Brien, Professor Ian McKeith

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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).

Abstract

Objectives: To pool clinical trials of similar design to assess overall sensitivity and specificity of ioflupane I123 injection (DaTSCAN or ioflupane (123I)) to detect or exclude a striatal dopaminergic deficit disorder (SDDD), such as parkinsonian syndrome and dementia with Lewy bodies.Design: Pooled analysis of three phase 3 and one phase 4 clinical trials. These four trials were selected because they were the four studies used for the US new drug application to the Food and Drug Administration (FDA).Setting: Multicentre, open-label, non-randomised.Participants: Patients with either a movement disorder or dementia, and healthy volunteers.Interventions: Ioflupane (123I) was administered.Outcome measures: 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 clinical diagnosis (reference standard) to determine sensitivity and specificity.Results: Pooling the four studies, 928 participants were enrolled, 849 were dosed and 764 completed their study. Across all studies, when images were assessed by on-site readers, ioflupane (123I) diagnostic effectiveness had an overall (95% CI) sensitivity of 91.9% (88.7% to 94.5%) and specificity of 83.6% (78.7% to 87.9%). When reads were conducted blindly by a panel of independent experts, the overall sensitivity was 88.7% (86.8% to 90.4%) and specificity was 91.2% (89.0% to 93.0%).Conclusions: In this pooled analysis, the visual assessment of ioflupane (123I) images provided high levels of sensitivity and specificity in detecting the presence/absence of an SDDD. Ioflupane (123I) imaging has the potential to improve diagnostic accuracy in patients with signs and symptoms of a movement disorder and/or dementia.

Publication metadata

Author(s): O'Brien JT, Oertel WH, McKeith IG, Grosset DG, Walker Z, Tatsch K, Tolosa E, Sherwin PF, Grachev ID

Publication type: Article

Publication status: Published

Journal: BMJ Open

Year: 2014

Volume: 4

Issue: 7

Print publication date: 03/07/2014

Online publication date: 03/07/2014

Acceptance date: 16/06/2014

Date deposited: 15/10/2014

ISSN (electronic): 2044-6055

Publisher: BMJ Publishing Group

URL: http://dx.doi.org/10.1136/bmjopen-2014-005122

DOI: 10.1136/bmjopen-2014-005122

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