title: Changes in clinical management and diagnosis following DaTscan SPECT imaging in patients with clinically uncertain parkinsonian syndromes: a 12-week follow-up study.
abstract: BACKGROUND
  An accurate diagnosis is important for timely and adequate treatment in patients with clinically uncertain parkinsonian syndrome (CUPS).
  
  
  OBJECTIVE
  The objective of this study was to assess safety and changes in clinical management, diagnosis and quality of life (QoL) at 4 and 12 weeks following DaTscan (ioflupane [(123)I] injection) imaging in patients with CUPS.
  
  
  METHODS
  This randomized, open-label, single-dose, multicenter trial was carried out in patients with CUPS who were randomized to either a DaTscan imaging group or to a control group without imaging. The main outcome measures were the proportions of patients with changes in clinical management and diagnosis from baseline through to 12 weeks after DaTscan. A total of 19 university hospital centers in Europe and the USA participated in the study. There were 267 patients enrolled and randomized (131 DaTscan, 136 control).
  
  
  RESULTS
  Significantly more DaTscan patients had changes in clinical management after 12 weeks (p = 0.004) compared to the control group, and significantly more DaTscan patients had changes in diagnosis at 4 weeks and at 12 weeks (both p < 0.001) compared to control patients. No significant difference in total score for QoL was observed between groups during the study duration. DaTscan was safe and well-tolerated. No deaths, serious adverse events (AEs) or withdrawals due to AEs occurred during the study. One patient had a headache following treatment with a suspected relationship to DaTscan.
  
  
  CONCLUSIONS
  DaTscan imaging significantly affected the clinical management and diagnosis of patients with CUPS. DaTscan is safe and well-tolerated and is a useful adjunct to differential diagnosis of CUPS.
authors.affiliation: Department of Neurology, Charité Campus Virchow-Kinikum, University Medicine Berlin, Berlin, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Kupsch
authors.forename: Nin
authors.initials: N
authors.lastname: Bajaj
authors.forename: Frederick
authors.initials: F
authors.lastname: Weiland
authors.forename: Antonio
authors.initials: A
authors.lastname: Tartaglione
authors.forename: Susanne
authors.initials: S
authors.lastname: Klutmann
authors.forename: Ronald
authors.initials: R
authors.lastname: Copp
authors.forename: Paul
authors.initials: P
authors.lastname: Sherwin
authors.forename: Ann
authors.initials: A
authors.lastname: Tate
authors.forename: Igor D
authors.initials: ID
authors.lastname: Grachev
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000978:Antiparkinson Agents / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D020367:Iofetamine; D008297:Male; D008875:Middle Aged; D020734:Parkinsonian Disorders / Q000175:diagnosis* / Q000000981:diagnostic imaging* / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D019275:Radiopharmaceuticals; D012720:Severity of Illness Index; D016037:Single-Blind Method; D013997:Time Factors; D015899:Tomography, Emission-Computed, Single-Photon / Q000379:methods*; D055815:Young Adult
chemical_list: D000978:Antiparkinson Agents; D019275:Radiopharmaceuticals; D020367:Iofetamine