GE Healthcare today presented the results of a randomized study analyzing the effect of DaTscan™ (Ioflupane I 123 Injection) SPECT imaging in a group of adult patients with clinically uncertain parkinsonian syndromes (CUPS) as part of 1-year follow up from imaging baseline. It was the first world-wide prospective trial including US experience, using selected endpoints in patients with CUPS. The findings, presented at the 2012 American Academy of Neurology Meeting, showed significant differences in clinical management, diagnosis, and physician confidence of diagnosis (CoD) for a group of patients with CUPS who had been imaged with DaTscan.
DaTscan is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected parkinsonian syndromes (PS). DaTscan may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson’s disease (PD), multiple system atrophy (MSA) and progressive supranuclear palsy (PSP)). DaTscan is an adjunct to other diagnostic evaluations. DaTscan was not designed to distinguish among PD, MSA and PSP. The effectiveness of DaTscan as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established.
This multi-center, randomized, open-label global (19 university hospital centers in US and Europe) clinical trial compared the clinical management, diagnosis and CoD of patients with CUPS who underwent DaTscan imaging (N=135) with those in the control group who did not (N=138). The full study evaluated patients at four weeks, 12 weeks and 52 weeks from baseline; imaging in the DaTscan group was performed 1 to 4 weeks from baseline. Results showed that significantly more patients in the DaTscan imaging group had at least one change in their clinical management from their baseline after 12 weeks (p = 0.002) and after 1 year (p < 0.001) compared with patients in the control group. Additionally, significantly more DaTscan imaging patients had a change from baseline in diagnosis and their physicians expressed greater CoD at all visits (all p < 0.001) compared with physicians of control patients.. In the DaTscan group, change in diagnosis at 1 year was found to be significantly higher among general neurologists (75%) compared with movement disorder specialists (47%; p<0.05 ). DaTscan was safe and well-tolerated in this trial.
In clinical trials, headache, nausea, vertigo, dry mouth or dizziness of mild to moderate severity were reported. In post-marketing experience, hypersensitivity reactions and injection site pain have been reported.
“These results show that in diagnosing patients experiencing symptoms of clinically uncertain PS, DaTscan may be clinically useful in helping neurologists and movement disorder specialists who may have difficulty confidently diagnosing patients using a clinical exam and other diagnostic tests,” said Igor Grachev, MD, PhD, Global Head of DaTscan, Medical Affairs, GE Healthcare, Medical Diagnostics who was a medical director for this trial. “In addition, physicians of patients who undergo the procedure may have greater confidence in their diagnoses, which may enable them to make more informed treatment decisions to better support and advise their patients.”