What is DaTSCAN?
DaTSCAN is a solution for injection that contains the active substance ioflupane (123I).
What is DaTSCAN used for?
DaTSCAN is intended for diagnostic use only. DaTSCAN is used to detect the loss of nerve cells in the area of the brain called the striatum. Specifically, the drug promotes the detection of nerve cells that release dopamine, a chemical substance responsible for the transmission of nerve impulses. The medicine is used to help diagnose:
• movement disorders such as in Parkinson's disease and other related diseases, in which the loss of striated nerve cells in the brain produces tremor, gait disturbance and muscle stiffness. However, these disorders can also manifest themselves in "essential tremor" (tremor of unknown cause) DaTSCAN helps discriminate between Parkinson's disease and essential tremor;
• dementia (loss of intellectual function): DaTSCAN is used to help discriminate between a type of dementia known as "dementia with Lewy bodies" and Alzheimer's disease.
The medicine can only be obtained with a prescription.
How is DaTSCAN used?
DaTSCAN should only be used in patients under the supervision of physicians experienced in the treatment of movement disorders and / or dementia. DaTSCAN should only be handled and administered by specialists experienced in the safe use of radioactive material.
Patients treated with DaTSCAN should also take another medicine (for example, iodine tablets) to reduce the absorption of the iodine contained in DaTSCAN by the thyroid gland. This medicine should be administered 1-4 hours before injection and again. 12-24 hours after DaTSCAN injection.DaTSCAN is given by slow intravenous injection (not less than 15-20 seconds) into a vein in the arm; the examination should be performed between 3 and 6 hours after the injection.
How does DaTSCAN work?
The active substance in DaTSCAN, ioflupane (123I), is a radiopharmaceutical containing a substance, called ioflupane, which has been labeled with 123I (iodine-123), a radioactive form of the chemical element iodine. Ioflupane binds to structures on the surface. nerve endings of cells in the area of the brain called the striatum and responsible for the transport of dopamine.
When DaTSCAN is given to a patient, ioflupane (123I) is distributed throughout the body through the bloodstream and accumulates in the striatum, where it binds to these cellular structures. The bond can be visualized using a special diagnostic imaging technique called SPECT (single photon emission computed tomography), which is capable of detecting radioactive iodine-123. If there is a loss of dopamine-containing nerve cells (which typically occurs in patients with Parkinson's disease), the bonds of DaTSCAN are greatly reduced and this effect is displayed on the scan.
How has DaTSCAN been studied?
In Parkinson's disease, DaTSCAN was studied in 254 patients in two studies. In both studies, images obtained from healthy volunteers (45 in total) were compared with those of patients with Parkinson's disease (180 patients). or essential tremor (29 patients).
In dementia DaTSCAN has been studied in 288 patients who have been diagnosed with dementia with Lewy bodies or Alzheimer's disease as well as some other form of dementia.
In all studies, the measure of effectiveness was the accuracy of the diagnosis based on the images obtained from the scan compared to the diagnosis made by a medical specialist.
What benefit has DaTSCAN shown during the studies?
In the main study in patients with Parkinson's disease and essential tremor, the sensitivity of DaTSCAN reached 96.5%. This means that the disease identified by the doctor responsible for reading the images obtained with DaTSCAN corresponded to the diagnosis already pronounced by the specialist in 96.5% of cases. The values relating to the sensitivity of DaTSCAN in discriminating potential dementia caused by Lewy bodies from other types of dementia ranged from 75.0% to 80.2%.
What is the risk associated with DaTSCAN?
Common side effects identified for DaTSCAN are increased appetite, headache, tingling and dizziness. The risk caused by radioactivity is considered to be extremely low. For the full list of side effects reported with DaTSCAN, see the package insert.
DaTSCAN must not be used in people who may be hypersensitive (allergic) to ioflupane or any of the other substances, or during pregnancy.
Why has DaTSCAN been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that DaTSCAN's benefits as a diagnostic agent are greater than its risks in order to facilitate the differentiation of essential tremor from Parkinsonian syndromes related to idiopathic Parkinson's disease, multiple system atrophy and progressive supranuclear palsy. as well as the differentiation of probable Lewy body dementia from Alzheimer's disease. The Committee therefore recommended the granting of a marketing authorization for the product.
More information on DaTSCAN
On 27 July 2000, the European Commission granted GE Healthcare Limited a "Marketing Authorization" for DaTSCAN, valid throughout the European Union. The "Marketing Authorization" was renewed on 27 July 2005.
For the complete version of the DaTSCAN EPAR click here.
Last update of this summary: 02-2007.
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