Findings from four pooled studies of brain biopsies showed the experimental PET imaging agent F-18 flutemetamol to have 93% sensitivity and 100% specificity in detecting beta amyloid plaque, which has been linked to Alzheimer's disease. Results of a brain autopsy study showed the agent diagnosed amyloid with an 86% sensitivity and 92% specificity.
In this video, Dr. Oliver Sartor of the Tulane Cancer Center in New Orleans explains a new trial approach that will use radiopharmaceutical radium-223 chloride, or Alpharadin, with the immunotherapy sipuleucel-T, or Provenge, to treat castration-resistant prostate cancer. Sartor said Alpharadin can release antigens, which makes cancer cells more vulnerable to treatments such as Provenge.
The Association of Clinical Research Organizations asked the FDA to accelerate the modernization of regulations covering U.S. clinical trials. Though there have been some advances in "developing basic building blocks," product development is still expensive, unproductive and slow, ACRO said. The group suggested the FDA hire a chief innovation officer who has the power to authorize new approaches to trials.
A Medical Imaging Confidence Index survey found that while radiology administrators expect to see growth in test volume and profit for January to June this year, they have "very low confidence" that Medicare reimbursements will be adequate. The survey involved 160 hospital imaging managers and directors.
The Michael J. Fox Foundation for Parkinson's Research, the Alzheimer's Association, JDRF and other patient advocacy groups increasingly match patients with clinical trials. More than half of trials in Phase II or III fail to complete enrollment within original timelines, and each year, 11% of research sites don't enroll any patients, according to Tufts University's Center for the Study of Drug Development.
A Senate panel on Wednesday cleared a bill that would allow the FDA to evaluate the safety of approved medical devices and give conditional approvals dependent on further studies. The measure also would tighten the agency's 510(k) process that permits firms to prove the similarity of their devices to products already approved without needing extensive trials.
Disagreements between the FDA and the health care industry could sink plans to establish a national system for tracking and tracing pharmaceuticals. A group of drug manufacturers, distributors and pharmacies says tracking drug lots rather than individual packages, as the FDA proposes, would be cheaper and simpler to implement.
The CMS on Tuesday issued a final rule intended to combat Medicare fraud and save almost $1.6 billion in costs over the next decade. A Government Accountability Office report, however, said more needs to be done and pressed the CMS to run pre- and post-payment claims evaluations and to address program vulnerabilities.
The SNM Annual Meeting — June 9-13 in Miami Beach, Fla. — is quickly approaching. Be sure to check out these popular sessions of interest including: Meet The Author Poster Sessions, PET Boot Camp: Mind, Body, and Spirit, Application-Specific Molecular Imaging, SPECT/CT Imaging: Clinical Role and Applications, Hybrid Nuclear-Magnetic Resonance Imaging Technologies, and Cardiac PET and SPECT 2012, plus so much more. Make your plans today!
Ideas are like rabbits. You get a couple and learn how to handle them, and pretty soon you have a dozen.
John Steinbeck, American writer
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