DUBLIN--(BUSINESS WIRE)--GE Healthcare today presented the results of a randomised controlled 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 at baseline versus no-imaging control group where DaTSCAN was collected at the study end.
It was the first and largest world-wide prospective trial including several centres from United States, using selected endpoints in patients with CUPS. The findings, presented at the 2012 Movement Disorders Society Meeting, showed significant differences in change in clinical management, diagnosis, and physician confidence of diagnosis (“CoD”) for a group of patients with CUPS who had been imaged with DaTSCAN.1
This multi-centre, randomised, open-label (19 university hospital centres in Europe and US) 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=0.022). DaTSCAN was 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.
“This is an important study for the industry,” said Nin Bajaj, Clinical Director of the National Parkinson Foundation Centre of Excellence, University of Nottingham. “These results show that DaTSCAN is a useful adjunct to the evaluation of the complex parkinsonian patient. Both physicians and patients may have greater confidence in their diagnoses according to the results of this study.”
DaTSCAN is a radiopharmaceutical indicated for striatal dopamine transporter visualisation using single photon emission computed tomography (SPECT) brain imaging. DaTSCAN was granted a Marketing Authorisation by the European Commission in July 2000 for use in detecting loss of functional dopaminergic neurons (nerve cells in the brain) in patients with clinically uncertain Parkinsonian syndrome (PS). In July 2006, the European indication was expanded to include differentiation of probable DLB from AD. DaTSCAN is currently licensed and distributed in more than 30 countries, and has been in clinical use for ten years in more than 300,000 patients worldwide.[i],[ii]
Parkinsonian syndromes (PS) are neurodegenerative disorders that affect a person’s ability to control movement and other muscle functions.2 Many people mistakenly attribute the first symptoms of PS, such as tremor, rigidity, or slow movement, to the normal aging process, and many have misconceptions about diagnosis of Parkinson’s disease (PD).
To learn more about DaTSCAN, visit www.DaTSCAN.com.
DaTSCAN is a radiopharmaceutical imaging agent that works by binding to dopamine transporters (DaT) in the brain. A specific marker for DaT, DaTSCAN produces images that provide visual evidence based on the density of dopamine transporters. DaTSCAN has been available in Europe since 2000 and has been used in nearly 300,000 patients in more than 30 countries.
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1 Igor D Grachev, Andreas Kupsch, Nin Bajaj et. al. Impact of DaTSCAN™ SPECT Imaging on Clinical Management, Diagnosis, and Confidence of Diagnosis in Patients with Clinically Uncertain Parkinsonian Syndromes: A Prospective 1-year Follow-up Study.
[i] Transcript from Peripheral and Central Nervous System Advisory Committee Meeting, August 11, 2009. Rockville, MD: U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 2009. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/UCM191398.pdf. Accessed October 12, 2010.
[ii] Data on file. GE Healthcare.
2 Parkinson’s 101. MJFF Website. http://www.michaeljfox.org/living_aboutParkinsons_parkinsons101.cfm. Accessed March 9, 2012.