RadNet Joins UCLA-Easton Center Alzheimer's Disease Research Study
LOS ANGELES, July 8, 2014 (GLOBE NEWSWIRE) -- RadNet Inc. (Nasdaq:RDNT), a national leader in providing high-quality, cost-effective, fixed-site outpatient diagnostic imaging services through a network of 250 owned and/or operated outpatient imaging
centers, announced it has joined a research study, the Imaging and Genetic Biomarkers for Alzheimer's Disease (ImaGene) study. The study is supported in part by GE Healthcare and sponsored by the Jim Easton Consortium for Alzheimer's Disease Drug Discovery and Biomarkers, and,
the National Institute of Aging.
The ImaGene study, launched by the UCLA-Easton Center in 2008, is a six-year long observational biomarker study. The purpose of the study is to investigate the potential interaction between genes, proteins, amyloid positron emission tomography (PET) imaging and MRI brain imaging in aging and the prodromal stages of Alzheimer's disease.
Vizamyl(TM) (Flutemetamol F18), a radioactive tracer used in PET imaging of the brain, will be employed in this trial. This tracer will be utilized to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment problem in support of the study. Vizamyl was approved by the U.S. Food and Drug Administration (FDA) in October 2013.
RadNet's Role in Alzheimer's Disease Study
Patients who meet the study protocol's criteria will have a PET/CT scan with Vizamyl at a RadNet radiology facility. The imaging will be performed at Liberty Pacific Advanced Imaging (Los Angeles) and Beverly Tower Advanced Imaging (Beverly Hills, CA).
"Beta amyloid radiotracers, such as Vizamyl, can help physicians and researchers to assess patients with cognitive impairment, including AD, and may help rule out AD as a diagnosis," said Judith Rose, M.D., RadNet medical director of PET/CT. "This collaboration builds upon an earlier research partnership with GE Healthcare where we evaluated Vizamyl prior to FDA approval."
"We are excited by the potential for these imaging techniques to help researchers better understand how Alzheimer's disease develops," said Dr. Rose. "RadNet's extensive experience with multiple new generation PET dementia imaging agents has helped advance some of the most promising AD research studies."
"The addition of an amyloid PET scan to this study may lead to a higher accuracy of disease ascertainment than we currently have in the parent project," said Liana Apostolova, M.D., UCLA associate professor-in-residence of neurology. "This supplemental information may help in future analyses. For instance, one might be able to ascertain which demographic, imaging, genetic or environmental factors including exercise, intellectual attainment or other variables, are associated with amyloid deposition or with rate of decline in the amyloid positive and negative groups. This will allow the study to identify how amyloid pathology possibly impacts these associations. As we investigate the molecular and genetic changes in those who are predestined to develop AD we can potentially uncover novel disease mechanisms and new therapeutic avenues."
Vizamyl(TM) and Beta Amyloid Imaging
Vizamyl (Flutemetamol F18) is a radioactive tracer indicated for PET imaging of the brain to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease or other causes of cognitive decline. Dementia associated with AD is related to multiple factors, including the accumulation of a protein called beta amyloid in the brain.
Vizamyl is one of only three FDA-approved PET radiotracers available for detecting beta amyloid and is the only PET imaging tracer for detection of amyloid approved by FDA for visual interpretation of color images. Vizamyl is an adjunct to other diagnostic evaluations.
A negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive scan indicates moderate to frequent amyloid neuritic plaques. This amount of amyloid neuritic plaque has been shown to be present in patients with AD but may also bepresent in patients with other neurologic conditions as well as in older people with normal cognition. Vizamyl is an adjunct to other diagnostic evaluations. A positive scan does not establish a diagnosis of AD or other cognitive disorder. The safety and effectiveness of Vizamyl have not been established for predicting the development of dementia or other neurologic conditions or for monitoring responses to therapies. The most commonly reported adverse reactions in NDA clinical trials were flushing (2 percent) and increased blood pressure, headache, nausea and dizziness (at 1 percent each).
Image interpretation is performed independently of the patient's clinical information. The use of clinical information in the interpretation of Vizamyl images has not been evaluated and may lead to errors. Extensive brain atrophy may limit the ability to distinguish grey and white matter on a Vizamyl scan. Motion artifacts may distort the image. Images should be interpreted only by readers who have completed a reader training program available from GE Healthcare.
About RadNet, Inc.
RadNet, Inc. is the leading national provider of freestanding, fixed-site diagnostic imaging services in the United States based on the number of locations and annual imaging revenue. RadNet has a network of 250 owned and/or operated outpatient-imaging centers (inclusive of 23 facilities held in joint ventures). RadNet's core markets include California, Delaware, Maryland, New Jersey, New York and Rhode Island. Together with affiliated radiologists, and inclusive of full-time and per diem employees and technologists, RadNet has a total of approximately 6,000 employees. For more information, visit RadNet.com.
About the UCLA-Easton Center
The Mary S. Easton Center for Alzheimer's Disease Research at UCLA (UCLA-Easton Center) is a comprehensive research center focused on Alzheimer's disease (AD) and other dementias. The theme of the Center is the therapeutic imperative, focusing on the overwhelming need for earlier (pre-dementia) diagnosis and new therapeutic agents that slow the course of AD and other dementias. Included in this theme is basic science study of the basic brain processes involved in AD, animal models of AD, clinical research of biomarkers for these diseases, diagnostic research and clinical trials of new medications. For more information please visit eastonad.ucla.edu.
Important Risk and Safety Information About Vizamyl(TM) (Flutemetamol F 18 Injection)
INDICATIONS AND USAGE: Vizamyl is indicated for positron-emission tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline. A negative scan indicates sparse to no neuritic plaques, inconsistent with a diagnosis of AD at the time of image acquisition. A negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive scan indicates moderate to frequent amyloid neuritic plaques. This amount of amyloid neuritic plaque has been shown to be present in patients with AD but may also be present in patients with other neurologic conditions as well as in older people with normal cognition. Vizamyl is an adjunct to other diagnostic evaluations. Limitations: A positive scan does not establish a diagnosis of AD or other cognitive disorder. The safety and effectiveness of Vizamyl have not been established for predicting the development of dementia or other neurologic conditions or for monitoring responses to therapies. CONTRAINDICATIONS: Known hypersensitivity to Vizamyl or any excipient, including polysorbate 80.
WARNINGS AND PRECAUTIONS -- Hypersensitivity Reactions: Reactions such as flushing and dyspnea have been observed within minutes following administration and may occur in patients with no history of exposure to Vizamyl. Have resuscitation equipment and trained personnel available. Image Misinterpretation: Errors may occur while interpreting Vizamyl PET images. Image interpretation is performed independently of the patient's clinical information. The use of clinical information in the interpretation of Vizamyl images has not been evaluated and may lead to errors. Extensive brain atrophy may limit the ability to distinguish grey and white matter on a Vizamyl scan. Motion artifacts may distort the image. Images should be interpreted only by readers who have completed a reader training program available from GE Healthcare. Radiation Risk: Like all radiopharmaceuticals, Vizamyl contributes to a patient's long-term, cumulative radiation exposure and cancer risk. Ensure safe handling to protect patients and healthcare workers from unintentional radiation exposure. ADVERSE REACTIONS: The most commonly reported adverse reactions in NDA clinical trials were flushing (2%) and increased blood pressure, headache, nausea, and dizziness (at 1% each). DRUG INTERACTIONS: Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Vizamyl image results. SPECIFIC POPULATIONS -- Pregnancy: It is not known whether Vizamyl can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. Radiopharmaceuticals, including Vizamyl, have the potential to cause fetal harm, the likelihood of which depends on the stage of fetal development and the magnitude of the radiopharmaceutical dose. Vizamyl should be given to a pregnant woman only if clearly needed. Nursing Mothers: It is not known whether flutemetamol is excreted in human milk. Because many drugs are excreted in human milk and there is a potential for radiation exposure to nursing infants, avoid use of Vizamyl in a breastfeeding mother or have the mother temporarily interrupt breastfeeding for 24 hours after exposure. Pediatric Use: Vizamyl is not indicated for use in pediatric patients. Geriatric Use: No overall differences in safety were observed between older and younger subjects. OVERDOSAGE: The clinical consequence of overdosing with Vizamyl has not been reported. It is unknown whether or not flutemetamol is dialyzable. In case of overdose of radioactivity, hydration and frequent urination should be encouraged.
Prior to Vizamyl administration, please read the Full Prescribing Information.