Highlights
- •Nearly all of the subjects in the registration studies of DaTscan™ Ioflupane I123 Injection were Caucasian.
- •A retrospective case-control study evaluated if diagnostic performance of [123I]ioflupane SPECT differed in non-Caucasians.
- •Diagnostic performance of [123I]ioflupane was comparable between Caucasians and non-Caucasians in this multicenter study.
Abstract
Purpose of the report
To compare diagnostic performance of [123I]ioflupane SPECT imaging in different racial groups. In previous registration trials
of [123I]ioflupane, 99% of the subjects enrolled were Caucasians.
Materials and methods
A multicenter retrospective case-control study was conducted to evaluate whether the
diagnostic performance of [123I]ioflupane SPECT imaging is different in non-Caucasians than in Caucasians matched
by age, sex, and final clinical diagnosis. Subjects who had received an initial diagnosis
of suspected Parkinson's disease (PD) or essential tremor (ET) and then underwent
[123I]ioflupane SPECT imaging to assist with the subject's final clinical diagnosis were
enrolled. Each subject's image was rated as normal or abnormal by 3 blinded expert
readers. The majority interpretation was then compared with the final clinical diagnosis.
Diagnostic performance of [123I]ioflupane SPECT imaging (as measured by positive percent agreement (equivalent to
sensitivity), negative percent agreement (equivalent to specificity), overall percent
agreement (OPA), and measures of inter-rater agreement) were compared between the
Caucasian and non-Caucasian groups.
Results
In total, 102 non-Caucasians (58 with PD and 44 with ET as a final clinical diagnosis)
and 102 Caucasians (58 with PD, 43 with ET, and 1 with “other”) were included in the
intent-to-diagnose (ITD) population. There was no significant difference between Caucasians
and non-Caucasians in the diagnostic performance of [123I]ioflupane SPECT imaging as measured by sensitivity, specificity, OPA, and measures
of inter-rater agreement.
Conclusion
In this study, the diagnostic performance of [123I]ioflupane SPECT imaging was comparable between Caucasians and non-Caucasians.
Abbreviations:
PD (Parkinson's disease), DaT (dopamine transporters), ET (essential tremor), ITD (intent-to-diagnose), OPA (overall percent agreement), PP (per-protocol), SD (standard deviation), SPECT (single-photon emission computed tomography.)Keywords
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Article info
Publication history
Published online: October 03, 2018
Accepted:
October 2,
2018
Received in revised form:
September 7,
2018
Received:
March 27,
2018
Identification
Copyright
© 2018 Elsevier B.V. All rights reserved.
