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Positron Emission Tomography Imaging News

Related terms: PET Imaging

FDA Approves Netspot (gallium Ga 68 dotatate) Imaging Agent to Detect Rare Neuroendocrine Tumors

Posted 16 Jun 2016 by Drugs.com

June 1, 2016 – The U.S. Food and Drug Administration today approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors (NETs). NETs are rare noncancerous (benign) or cancerous (malignant) tumors that develop in the hormone-producing cells of the body’s neuroendocrine system. These cells are found throughout the body in organs, such as the stomach, intestines, pancreas, lungs and other locations. NETs have receptors for somatostatin, a hormone that regulates the endocrine system. Ga 68 dotatate, a positron emitting analogue of somatostatin, works by binding to such receptors. "Use of advanced imaging techniques to detect rare ... Read more

Related support groups: Diagnosis and Investigation, Positron Emission Tomography Imaging, Netspot, Neuroendocrine Carcinoma

FDA Approves Axumin (fluciclovine F 18) Diagnostic Imaging Agent to Detect Recurrent Prostate Cancer

Posted 1 Jun 2016 by Drugs.com

May 27, 2016 – The U.S. Food and Drug Administration today approved Axumin, a radioactive diagnostic agent for injection. Axumin is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment. Prostate cancer is the second leading cause of death from cancer in U.S. men. In patients with suspected cancer recurrence after primary treatment, accurate staging is an important objective in improving management and outcomes. “Imaging tests are not able to determine the location of the recurrent prostate cancer when the PSA is at very low levels,” said Libero Marzella, M.D., Ph.D., director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research. “Axumin is shown to provide another accurate imaging approach for these patient ... Read more

Related support groups: Prostate Cancer, Diagnosis and Investigation, Axumin, Fluciclovine F 18, Positron Emission Tomography Imaging

FDA Approves Neuraceq (florbetaben F18 injection) for PET Imaging of Beta-Amyloid Plaques

Posted 20 Mar 2014 by Drugs.com

Berlin/Boston, March 20, 2014‒ Piramal Imaging today announced that the U.S. Food and Drug Administration (FDA) has approved Neuraceq. This approval comes only four weeks after receiving marketing authorization for Neuraceq from the European Commission. Neuraceq 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. There are an estimated 7.7 million new cases of dementia each year worldwide. 1 Alzheimer’s disease accounts for 60-80% of all dementia diagnoses. 2 However, a clinical diagnosis of probable AD is incorrect upon post-mortem histological investigation in 10-30% of cases.3 The Centers for Medicare & Medicaid Services (CMS) has declared it will cover a beta-amyloid PET scan fo ... Read more

Related support groups: Dementia, Alzheimer's Disease, Diagnosis and Investigation, Positron Emission Tomography Imaging

Brain-Imaging Drug Vizamyl Approved for Alzheimer's Detection

Posted 11 Nov 2013 by Drugs.com

FRIDAY, Oct. 25 – Vizamyl (flutemetamol F 18 injection) has been approved by the U.S. Food and Drug Administration for use with positron emission tomography (PET) imaging of the brain to screen adults for signs of Alzheimer's disease and other forms of dementia. Dementia – characterized by deteriorating memory, judgment, language and motor skills – has been associated with brain accumulation of a protein called beta amyloid. Vizamyl, combined with a PET scan, can help doctors detect this protein, the FDA said Friday in a news release. Vizamyl, the second diagnostic drug approved for this purpose, was evaluated in clinical studies of 761 people. The injected drug is not meant to predict whether a person will go on to develop Alzheimer's or other types of dementia, or to evaluate how people may respond to dementia therapies, the FDA warned. Potential side effects of the drug include ... Read more

Related support groups: Alzheimer's Disease, Diagnosis and Investigation, PET Imaging, Positron Emission Tomography Imaging

Newly Approved Imaging Agent Choline C 11 Helps Find Prostate Cancer

Posted 12 Sep 2012 by Drugs.com

WEDNESDAY, Sept. 12 – Choline C 11, an imaging agent used for positron emission tomography (PET) testing, has been approved to help detect recurring prostate cancer, the U.S. Food and Drug Administration said Wednesday in a news release. The injected substance helps produce an image that allows doctors to identify tissues to test for the disease, the agency said. It warned that PET testing was not a substitute for testing of the actual tissue. PET testing is performed in men who have elevated blood levels of prostate specific antigen (PSA), a sign that prostate cancer could be present, the FDA said. In reviewing four previously published studies, the agency said it found that "at least half" of men who had abnormalities detected in PET scans "also had recurrent prostate cancer confirmed by tissue sampling of the abnormal areas." The FDA said side effects of the newly approved agent ... Read more

Related support groups: Prostate Cancer, Diagnosis and Investigation, Positron Emission Tomography Imaging

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Vizamyl, Amyvid, Neuraceq, Axumin, Netspot, Cardiogen-82, gallium ga 68 dotatate, florbetapir f 18, flutemetamol f 18, florbetaben f-18, fluciclovine f 18, rubidium chloride rb-82