GE Healthcare’s DaTscan (Ioflupane 123I injection) SPECT Imaging significantly affected clinical management and diagnosis of patients with a clinically uncertain Parkinsonian syndrome and can be a useful adjunct for the assessment of movement disorders, according to data presented at the American Academy of Neurology meeting this week in Honolulu.
Each year, 50,000 to 60,000 new cases of Parkinson’s disease are diagnosed in the U.S., but an accurate diagnosis can take up to six years. DaTscan imaging, approved by the FDA in January, depicts loss of functional striatal dopaminergic neuron terminals in patients with degenerative forms of Parkinsonian syndrome.
The objective of the multi-center, open-label, randomized clinical trial was to assess the impact of DaTscan imaging on the management plan, diagnosis, confidence of diagnosis, safety and quality of life parameters in patients with a clinically uncertain Parkinsonian syndrome, according to Andreas R. Kupsch, MD, PhD, from the department of neurology, Charite-University Medicine Berlin, and colleagues.
The interim results showed that more patients in the DaTscan group (n=107) had changes in diagnosis compared with the control group (n=122) at both four weeks (42 percent vs. 9 percent) and 12 weeks (44 percent vs. 12 percent) and their physicians had a higher mean confidence of diagnosis in patients imaged with DaTscan.
Additionally, in patients with a management plan at baseline who completed 12 weeks of the study (n=113 DaTscan and 125 control), significantly more DaTscan patients had management changes (49 percent vs. 31 percent) compared to the control group, according to Kupsch and colleagues.
However, quality of life responses were similar in both groups at four and 12 weeks post-randomization.
“Interim clinical results show that DaTscan can be useful in providing objective evidence for patients with diagnostic uncertainty,” said Frederick Weiland, MD, co-director of nuclear medicine at Sutter Medical Group Diagnostic Medical Imaging in Sacramento, Calif. “In addition, physicians of patients participating in the study had more confidence in their diagnosis and recommended treatment when they had a DaTscan image,” added Weiland.
Overall, DaTscan significantly affected clinical management and diagnosis of patients with a clinically uncertain Parkinsonian syndrome. These interim results further support the use of DaTscan as a safe and useful adjunct for the assessment of movement disorders, concluded Kupsch and colleagues.