title: Is ioflupane I123 injection diagnostically effective in patients with movement disorders and dementia? Pooled analysis of four clinical trials.
abstract: OBJECTIVE
  To pool clinical trials of similar design to assess overall sensitivity and specificity of ioflupane I123 injection (DaTSCAN or ioflupane ((123)I)) to detect or exclude a striatal dopaminergic deficit disorder (SDDD), such as parkinsonian syndrome and dementia with Lewy bodies.
  
  
  METHODS
  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).
  
  
  METHODS
  Multicentre, open-label, non-randomised.
  
  
  METHODS
  Patients with either a movement disorder or dementia, and healthy volunteers.
  
  
  METHODS
  Ioflupane ((123)I) was administered.
  
  
  METHODS
  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 ((123)I) 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 ((123)I) images provided high levels of sensitivity and specificity in detecting the presence/absence of an SDDD. Ioflupane ((123)I) imaging has the potential to improve diagnostic accuracy in patients with signs and symptoms of a movement disorder and/or dementia.
  
  
  BACKGROUND
  NCT00209456.
authors.affiliation: Department of Psychiatry, University of Cambridge School of Clinical Medicine, and Cambridgeshire and Peterborough Foundation NHS Trust, Cambridge, UK.
authors.forename: John T
authors.initials: JT
authors.lastname: O'Brien
authors.affiliation: Department of Neurology, Philipps-University of Marburg, Marburg, Germany.
authors.forename: Wolfgang H
authors.initials: WH
authors.lastname: Oertel
authors.affiliation: Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Ian G
authors.initials: IG
authors.lastname: McKeith
authors.affiliation: Department of Neurology, Institute of Neurological Sciences, Southern General Hospital, and University of Glasgow, Glasgow, Scotland, UK.
authors.forename: Donald G
authors.initials: DG
authors.lastname: Grosset
authors.affiliation: Mental Health Sciences Unit, University College London, London, UK North Essex Partnership University NHS Foundation Trust, Essex, UK.
authors.forename: Zuzana
authors.initials: Z
authors.lastname: Walker
authors.affiliation: Department of Nuclear Medicine, Municipal Hospital Karlsruhe, Inc., Karlsruhe, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Tatsch
authors.affiliation: Neurology Service, Hospital Clínic, University of Barcelona, Institut d'investigacions Biomédiques August Pi i Sunyer (IDIBAPS),Centro de Investigación Biomédica en Red de Enfermedades Neurodegenerativas (CIBERNED), Barcelona, Catalonia, Spain.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Tolosa
authors.affiliation: Clinical Development, Life Sciences, GE Healthcare, Princeton, New Jersey, USA.
authors.forename: Paul F
authors.initials: PF
authors.lastname: Sherwin
authors.affiliation: Global Head of Neurology/DaTscan, Medical Affairs, Life Sciences, GE Healthcare, Princeton, New Jersey, USA.
authors.forename: Igor D
authors.initials: ID
authors.lastname: Grachev
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017326:Clinical Trials, Phase III as Topic; D017327:Clinical Trials, Phase IV as Topic; D003704:Dementia / Q000000981:diagnostic imaging*; D005260:Female; D006801:Humans; D007267:Injections; D007457:Iodine Radioisotopes / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009069:Movement Disorders / Q000000981:diagnostic imaging*; D009662:Nortropanes / Q000008:administration & dosage; D011877:Radionuclide Imaging; D019275:Radiopharmaceuticals; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D007457:Iodine Radioisotopes; D009662:Nortropanes; D019275:Radiopharmaceuticals; C519528:ioflupane