HONOLULU, April 13, 2011 /PRNewswire/ -- Today, GE Healthcare announced interim results of a recently completed randomized study of the impact of DaTscan™ SPECT imaging on the clinical management and diagnosis of adult patients who exhibit signs or symptoms of parkinsonian syndromes (PS). The results, presented at the 2011 American Academy of Neurology Meeting, are an important step in documenting the value of DaTscan 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 US Food and Drug Administration in January 2011.
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% vs. 31%) 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, MD, 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 sixty thousand new cases of Parkinson's disease (PD), a form of PS, are diagnosed in the US each year,(1) 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. DaTscan is an adjunct to other diagnostic evaluations to help differentiate ET from conditions with similar symptoms.
"We believe that DaTscan imaging may contribute to reduced healthcare expenditures over time by preventing patients from receiving misdiagnoses or inappropriate treatment," said Stephen Lightfoot, MI-SPECT Segment Leader, GE Healthcare Medical Diagnostics. "GE Healthcare is committed to ensuring that DaTscan is used in appropriate patients at the right time and that neurologists have access to the necessary tools."
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 32 countries. DaTscan is classified as a Schedule II controlled substance. A Schedule II controlled substance is a substance with a currently accepted medical use in the US (with or without severe restrictions) that has a high potential for abuse that may lead to severe psychological or physical dependence, as determined by the Controlled Substances Act. 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 efficacy of 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 consistent performance of 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 (Ioflupane I 123 Injection)
INDICATIONS AND USAGE - 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, multiple system atrophy and progressive supranuclear palsy). DaTscan is an adjunct to other diagnostic evaluations. 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 may consider 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; and 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.
Prior to DaTscan administration, please read the Full Prescribing Information.
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(1) Parkinson's Disease (PD) Overview. National Parkinson Foundation Web site. http://www.parkinson.org/parkinson-s-disease.aspx. Accessed March 28, 2011.
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