Reston, VA-- The SNM Clinical Trials Network has announced that a prototype clinical PET oncology imaging simulator -- or "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 Network-as part of its mission to ensure standardization and harmonization across multiple imaging sites participating in clinical trials-evaluates images produced by phantoms to ensure that molecular imaging centers are providing consistent and accurate images. Imaging consistency among sites-both in the technology used and images produced-is 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 single trial.

"The network's phantom program draws upon an SNM phantom imaging program that has been operational for over ten years. In addition, SNM maintains a group of experts who evaluate a center's image quality," said Paul E. Christian, chair of the Clinical Trials Network's Phantom Subcommittee and associate director of molecular imaging at the Huntsman Cancer Institute, University of Utah. "Based on these phantom images, experts can help imaging centers by recommending adjustments in the image acquisition parameters to produce images of a very high quality."

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