April 14, 2011 – Interim results from a randomized study on the impact of a SPECT imaging system on clinical management and diagnosis of adult patients who exhibit signs or symptoms of parkinsonian syndromes (PS) have been released. The study used GE Healthcare’s DaTscan system.
The results, presented at the 2011 American Academy of Neurology Meeting, are an important step in documenting the value of the system 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 U.S. Food and Drug Administration (FDA) in January 2011. It is a radiopharmaceutical imaging agent that works by binding to dopamine transporters (DaT) in the brain.
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 percent vs. 31 percent) 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, M.D., 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 60,000 new cases of Parkinson’s disease (PD), a form of PS, are diagnosed in the United States each year, but an accurate diagnosis can take up to six years. Many people mistakenly attribute the first symptoms of PD to the normal aging process, and many have misconceptions about diagnosis.
Use of DaTscan imaging may enable appropriate management for adult patients who have signs or symptoms of PS, through timely, appropriate diagnosis. PS occurs when the brain does not get enough dopamine to perform certain functions. This affects the ability of the brain to control movement and other muscle functions.