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SNM clinical trials network expands phantom program for evaluating imaging centers
Date:4/14/2009

Reston, Va.The SNM Clinical Trials Network has announced that a prototype clinical PET oncology imaging simulatoror "phantom"has been successfully scanned and imaged at four imaging centers. SNM intends to deliver and scan the phantom at an additional 20 imaging centers by the end of September.

SNM's Clinical Trials Networkas part of its mission to ensure standardization and harmonization across multiple imaging sites participating in clinical trialsevaluates images produced by phantoms to ensure that molecular imaging centers are providing consistent and accurate images. Imaging consistency among sitesboth in the technology used and images producedis critical for ensuring quality imaging and quantitative data and is essential to meet Food and Drug Administration (FDA) requirements for investigational clinical trials.

"The community agrees that a lack of uniformity across imaging sites is a primary barrier to using imaging in clinical trials to facilitate drug development," said Michael Graham, Ph.D., M.D., co-chair of SNM's Clinical Trials Network and director of nuclear medicine at the University of Iowa Carver College of Medicine. "When pharmaceutical companies apply to FDA for approval of a new product, they must first demonstrate a certain level of disease detectability as evidenced by some imaging measurement. Many of the denials of new drugs are based on a rejection of data compiled from poor-quality images or images that don't appear to match those from another similar study."

Successfully scanning phantoms is one part of the overall process that the network will use to "validate" imaging sites for future clinical trials. Imaging of the PET phantoms, which contain a known quantity and distribution of radioactivity, will be used to evaluate each site's imaging capabilities both qualitatively and quantitatively and ensure standardization and compliance with defined protocols in order to ensure consistency across multiple centers in a sing
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Contact: Amy Shaw
ashaw@snm.org
703-652-6773
Society of Nuclear Medicine
Source:Eurekalert

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