Complimenting the DaTscan study with the post-scan DaTQUANT™ analytical tool
Each year, between 50,000 and 60,000 new cases of Parkinson’s disease are diagnosed in the United States. It is estimated that as many as one million people around the country suffer from the condition. A timely and correct diagnosis can help patients and their families overcome the fears and frustrations associated with getting an accurate diagnosis so they can move on with their lives.
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 of the presence of dopamine transporters. DaTscan™ has been available in Europe since 2000 and has been used in nearly 300,000 patients in 32 countries.
In 2011, the US Food and Drug Administration (FDA) approved DaTscan™ (Ioflupane I 123 Injection) for use as an imaging agent with single photon emission computed tomography (SPECT) imaging. This agent aids detection of dopamine transporters (DaT) in the brains of adult patients with suspected Parkinsonian syndromes (PS). Dopamine is a brain chemical that is classified as a neurotransmitter and is found in regions of the brain that regulate activities such as movement and emotion.
DaTscan™ is the first FDA-approved diagnostic imaging agent to help physicians evaluate neurodegenerative movement disorders, such as idiopathic (of unknown cause) Parkinson’s disease (PD). This agent may be used in conjunction with other diagnostic evaluations to help differentiate essential tremor (an involuntary shaking of the hands, head, and voice) from tremor due to PS. DaTscan™ cannot differentiate between the different types of PS.
DaTQUANT™ is an analytical tool that enhances the radiologist’s reading of each DaTscan study. This tool offers doctors a visual evaluation of the images acquired during the imaging exam, with this evaluation further assisting the detection of Parkinson’s disease.
The benefit DaTQUANT™ provides to doctors is that the results are automatically generated through the analysis, can be reproduced repeatedly for validation, and are very accurate.
A bone scan helps your doctor evaluate how your bones are working, and provides information to help diagnose and treat your condition. It can show injury to the bones, the effects of disease such as cancer or infection, as well as any improvement or deterioration in a bone abnormality after any treatment you might be having.
With this type of statistical validation, this provides increased diagnostic confidence for the physician that their patient either has Parkinson’s disease or does not.
“Ioflupane [DaTscan] may be an important new imaging agent for physicians in differentiating diseases such as Parkinson’s disease from Essential Tremor,” said Mark Stacy, MD, neurologist and director of the Duke Movement Disorders Clinic at Duke University Medical Center in Durham, NC. “Understanding exactly what you are dealing with is important in selecting the appropriate treatments for patients with movement disorders.”
The FDA’s action, following a Priority Review, marks the approval of the first radiopharmaceutical agent to detect DaT distribution within the brain. Visualization of DaT distribution within the brain may help decrease diagnostic uncertainty in adult patients with suspected PS. The FDA granted DaTscan™ Priority Review due to an unmet clinical need for an imaging agent to assist physicians in managing patients according to their dopaminergic status. Parkinsonian syndromes are a group of neurodegenerative disorders (including multiple system atrophy, progressive supranuclear palsy and idiopathic Parkinson’s disease) characterized by rigidity, tremor and an impaired ability to walk.
“Currently, movement disorders are diagnosed through clinical examinations, blood tests and neuropsychological evaluations, which are not conclusive and may lead to misdiagnosis,” Dr. Stacy said. “A new diagnostic adjunct to existing clinical assessments represents a meaningful contribution to the movement disorders field.”
The FDA’s approval of DaTscan™ 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.
“We are confident that DaTscan™, an objective and accurate marker of dopamine transporters, will better inform physicians’ diagnostic decisions,” said Stephen Lightfoot, MI-SPECT Segment Leader, GE Healthcare Medical Diagnostics. “By potentially enabling better disease management, we expect that DaTscan will greatly benefit the patient community.”
What is a parkinsonian syndrome?
Parkinsonian syndromes (PSs) are a group of disorders (idiopathic Parkinson’s disease, multiple system atrophy, and supranuclear palsy) that may occur when there is a reduction in the ability of dopamine, an essential chemical that works in the brain, to function normally.
Dopamine affects many normal brain functions, impacting our behavior, thought, attention, sleep, motivation, and movement. There may also be a loss of proteins called dopamine transporters or receptors, known as DaT, which also may impact how dopamine functions in the brain.
When there is a deficiency in dopamine, the brain may not be able to perform certain tasks. One of the problems caused by a dopamine deficiency is the inability of the brain to control movement and motor functions. The signs and symptoms of PS may be a result of a dopamine deficiency.
Different parkinsonian syndromes
There are different types of parkinsonian syndromes. One of the most common disorders is Parkinson’s disease, also known as PD, which affects an estimated one million Americans. Other types of parkinsonian syndromes include multiple system atrophy and progressive supranuclear palsy.
Common movement disorder symptoms
Are you or your loved one experiencing any of these symptoms?
- Slowness of movement
- Difficulty with balance
- Stiff facial expression
- Shuffling walk
- Muffled speech or soft voice
If you or a loved one are experiencing any of the symptoms mentioned, it may be caused by a PS or essential tremor (ET).
If you or a loved one have a movement disorder, such as PS or ET, you or your loved one may have trouble performing everyday tasks.
When symptoms of a movement disorder such as PS or ET appear, they may be mistaken for other conditions, especially in the elderly. You should talk to your doctor if you feel that you or a loved one is experiencing any symptoms that you believe may be related to a movement disorder. The doctor will evaluate your or your loved one’s symptoms and medical history and decide whether testing would be helpful.
It is important to note that symptoms may be different from patient to patient. Many patients experience some symptoms and not others. The progression of the disease, including how quickly or how slowly the disease worsens, may vary on an individual basis.
You should not have a DaTscan if You are sensitive to iodine or any of the components of DaTscan; your doctor can help you understand what these ingredients are.
The most common side effects of DaTscan are headache, upset stomach, a sensation of motion, dry mouth, or dizziness has occurred in fewer than one out of every 100 patients.
Some drugs may interfere with the DaTscan-enhanced picture. Be sure to tell your doctor what drugs you are taking so that he or she can decide whether you should stop any of them for a period of time before using DaTscan. Always talk to your doctor if you have any questions about SPECT imaging or the use of DaTscan.
DaTscan studies are performed at the Diagnostic Imaging Services Metairie – Veterans Memorial Boulevard and Covington – Highway 21 locations. We are the only independently-owned outpatient imaging facility to perform this complete study that includes not only the scan but the statistical analysis provided by DaTQUANT™.