GE Healthcare Presents Interim Data on the Impact of DaTscanâ„¢ (Ioflupane I 123 Injection) SPECT Imaging on the Diagnosis and Clinical Management of Patients with Clinically Un...
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