HONOLULU, April 13, 2011 /PRNewswire/ — Today, GE Healthcare
announced interim results of a recently completed randomized study
of the impact of DaTscan™ SPECT imaging on the clinical
management and diagnosis of adult patients who exhibit signs
or symptoms of parkinsonian syndromes (PS). The results, presented
at the 2011 American Academy of Neurology Meeting, are an important
step in documenting the value of DaTscan as an adjunct diagnostic
tool for use in differentiating between PS and disorders such
as essential tremor (ET) that have similar symptoms. DaTscan was
approved by the US Food and Drug Administration in January
2011.
This multi-center, open label, randomized clinical trial
compared the management, diagnosis, confidence of diagnosis (CoD),
and quality of life (QoL) at four, 12 weeks and 52 weeks after
randomization to either undergo DaTscan SPECT imaging (N=1331
randomized; 119 dosed and scanned) or not (N=136). The full study
will evaluate patients through one year from baseline. Interim
results showed more patients in the DaTscan group had changes from
baseline (pre-DaTscan) diagnosis and their physicians had a higher
mean CoD compared with the control group at both four and 12 weeks
post-randomization. Additionally, in patients with a management
plan at baseline (N=113 DaTscan and 125 control), significantly
more DaTscan patients had management changes 12 weeks after
randomization (49% vs. 31%) compared to the control group
(p=0.004).
“Interim clinical results show that DaTscan can be useful in
providing objective evidence for patients with diagnostic
uncertainty,” said Frederick Weiland, MD, Sutter Medical Group
Diagnostic Medical Imaging Co-Director of Nuclear Medicine. “In
addition, physicians of patients participating in the study had
more confidence in their diagnosis and recommended treatment when
they had a DaTscan image.”
Fifty thousand to sixty thousand new cases of Parkinson’s
disease (PD), a
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