Background This study assessed the impact of DaTscan on clinical management, diagnosis, confidence of diagnosis (CoD), quality of life (QoL), health resource use (HRU) and safety during a 1-year follow-up in patients with clinically uncertain parkinsonian syndromes (CUPS).
Methods A total of 19 university hospital centres in Europe and the USA participated in this open-label, single-dose, prospective, clinical trial in patients with CUPS who were randomised to a DaTscan imaging group or to a no-imaging (control) group. The proportion of patients with changes in clinical management, diagnosis, CoD, QoL and HRU from baseline through 1 year post-DaTscan was compared between groups.
Results There were 273 patients randomised (135 DaTscan, 138 control). Significantly more patients in the DaTscan imaging group had at least one change in their actual clinical management after 12 weeks (p=0.002) and after 1 year (p<0.001) compared with patients in the control group. In addition, significantly more DaTscan patients had changes in diagnosis and an increased CoD at 4 weeks, 12 weeks and 1 year (all p<0.001) compared with control patients. No significant differences in total score for QoL or HRU were observed between groups during the 1-year follow-up period. DaTscan was safe and well tolerated. One patient in the imaging group had an adverse event (headache) with suspected relationship to DaTscan post-administration.
Conclusions DaTscan had a significant impact on clinical management, diagnosis and CoD in patients with CUPS. DaTscan is safe and well tolerated, and is a useful adjunct to differentiate a diagnosis of CUPS.
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Funding This study was sponsored by GE Healthcare, Princeton, NJ, USA.
Competing interests PS, AT and IDG are employees of GE Healthcare. MB is employee of i3 Statprobe. ARK, NB, FW, AT and SK declare no competing interests.
Patient consent Obtained.
Ethics approval Ethics approval was provided by 19 different institutional ethics committees and institutional review boards (one per centre) in Europe and the USA.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement MB from i3 Statprobe had full access to the raw data set and takes responsibility for the integrity of the data and the accuracy of the data analysis. All results of the study were shared among all co-authors.
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