DaTscan™ (Ioflupane I 123 Injection) SPECT Imaging Demonstrates Impact on the Diagnosis and Clinical Management of Patients with Clinically Uncertain Parkinsonian Syndrome

24 April 2012

DaTscan™ (Ioflupane I 123 Injection) SPECT Imaging Demonstrates Impact on the Diagnosis and Clinical Management of Patients with Clinically Uncertain Parkinsonian Syndrome

 

New data showing physician confidence in DaTscan diagnostic toolpresented at 2012 American Academy of Neurology Meeting

New Orleans, Louisiana – April 24, 2012 –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.[i]

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.¹ 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.”

Parkinsonian syndrome (PS) is a neurodegenerative disorder that affects a person’s ability to control movement and other muscle functions.[ii] 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). A recent survey by the National Parkinson Foundation found that 33 percent of Americans believe that a blood test can detect PD, while 30 percent did not know.[iii]

Although doctors can run blood tests to help diagnose a number of conditions, they cannot diagnose PD based on the results of a blood test.³Despite the unavailability of a simple test, DaTscan™ (Ioflupane I 123 Injection) may be used as an adjunct to other diagnostic tests to assist in differentiating PS from conditions with similar symptoms, like essential tremor (ET).

“These results build on our existing knowledge of the safety and efficacy of DaTscan as an adjunct to assist in diagnosis of patients with symptoms of parkinsonian syndromes,” said Terri Moench, General Manager, SPECT, GE Healthcare, Medical Diagnostics. "By providing patients with a timely, accurate diagnosis, physicians can work quickly and closely with them to develop an appropriate treatment plan.”

To learn more about DaTscan, visit www.datscan.com.

About DaTscan

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 34 countries. DaTscan is classified as a Schedule II controlled substance. A DEA license is required for the handling or administration of controlled substances.

FDA approval was based on two phase 3 clinical trials confirming the safety and efficacy of SPECT imanging with DaTscan for the visualization of DaT distribution within the striata, an interior part of the brain. These studies, evaluating 284 adult patients with tremor, demonstrated the performance of SPECT imaging with DaTscan in the visual detection of DaT distribution in the brain when compared with a reference clinical diagnosis.

Important Risk and Safety Information about DaTscan

INDICATIONS AND USAGE -DaTscan is a radiopharmaceutical indicated forstriataldopamine 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, multiple system atrophy and progressive supranuclear palsy).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.CONTRAINDICATIONS - DaTscan is contraindicated in patients with known hypersensitivity to the active substance, any of the excipients, or iodine.WARNINGS AND PRECAUTIONS - Hypersensitivity Reactions -Hypersensitivity reactions, generally consisting of skin erythema and pruritis, have been reported following DaTscan administration. Thyroid Accumulation - The DaTscan injection may contain up to 6% of free iodide (iodine 123 or I-123).To decrease thyroid accumulation of I-123, block the thyroid gland at least 1 hour before administration of DaTscan; failure to do so may increase the long-term risk for thyroid neoplasia.ADVERSE REACTIONS - In clinical trials, headache, nausea, vertigo, dry mouth or dizziness of mild to moderate severity were reported. In postmarketing experience, hypersensitivity reactions and injection site pain have been reported. DRUG INTERACTIONS - Drugs that bind to the dopamine transporter with high affinity may interfere with the DaTscan image.The impact of dopamine agonists and antagonists upon DaTscan imaging results has not been established.SPECIFIC POPULATIONS – Pregnancy - It is unknown whether DaTscan can cause fetal harm or increase risk of pregnancy loss in pregnant women. DaTscan should be given to pregnant women only if clearly needed.Like all radiopharmaceuticals, DaTscan may cause fetal harm depending on the stage of fetal development, and the magnitude of the radionuclide dose. Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function.Nursing Mothers - It is not known whether DaTscan is excreted into human milk, however, I-123 is excreted into human milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of DaTscan or not to administer DaTscan. Nursing women mayconsider interrupting nursing and pump and discard breast milk for 6 days after DaTscan administration to minimize risks to a nursing infant.Pediatric Use -The safety and efficacy of DaTscan have not been established in pediatric patients.Geriatric Use -There were no differences in responses between the elderly and younger patients that would require a dose adjustment.Renal and Hepatic Impairment - The effect of renal or hepatic impairment upon DaTscan imaging has not been established. The kidney excretes DaTscan; patients with severe renal impairment may have increased radiation exposure and altered DaTscan images. DRUG ABUSE AND DEPENDENCE - Ioflupane I 123 Injection is a DEA Schedule II controlled substance. A DEA license is required for handling or administering this controlled substance. OVERDOSAGE -It is unknown whether or not ioflupane is dialyzable. The major risks of overdose relate to increased radiation exposure and long-term risk for neoplasia. In case of radioactivity overdosage, frequent urination and defecation should be encouraged to minimize radiation exposure to the patient.PROCEDURE - Radiation Safety -DaTscan emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients.

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[i] 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. Poster presented at 2012 American Academy of Neurology Annual Meeting.
[ii] Parkinson’s 101. MJFF Website.http://www.michaeljfox.org/living_aboutParkinsons_parkinsons101.cfm. Accessed March 9, 2012.
[iii] National Parkinson Foundation Survey Results. March 2011.

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