Proving the Value of Registries

This issue provides updates on several important applications of molecular imaging. The cover story presents novel ideas to better identify patients who are at risk for or have coronary artery disease. Over the last decades, SPECT, rest/stress myocardial perfusion has become the cornerstone for detection and risk-stratification of coronary artery disease. More recently, non-contrast, CT-based calcium scoring has entered the clinical arena which can also be used to predict the patients’ risks for subsequent cardiac events. CT coronary angiography also has been used to monitor changes in plaque morphology in response to lipid lowering interventions. In addition, myocardial perfusion imaging with PET and 82 Rubidium is gaining increasing acceptance in the management of cardiac patients. The featured story discusses reasonable approaches to use multiple imaging tests for diagnosing and managing coronary artery disease.

In another area of medicine, important clinical trials in cancer that involve or center around PET imaging are ongoing. These studies have been designed by the American College of Radiology Imaging Network (ACRIN), the National Cancer Institute (NCI), the National Oncologic PET Registry (NOPR) group, the Academy of Molecular Imaging (AMI) and by the clinical trials network of the SNM. Some of these involve novel (or rediscovered) imaging probes such as 18F-FLT or 18F-sodium fluoride, while others follow in design the example of the National Oncologic PET Registry (NOPR). However, there are still too few clinical trials that would pave the way for using PET as an early therapy response marker. This, as well as continuing efforts among professional societies to standardize PET image acquisition and analysis as well as defining PET-based therapy response criteria, are prerequisites for the acceptance of PET imaging in the oncology community.

The NOPR group has established a new registry to collect data on 18F-sodium fluoride imaging for detecting bone metastases. To meet some of the above-listed criteria for reimbursement, this registry goes beyond just accuracy data and will include impact on patient management as well as outcome data. At the same time, a multicenter trial is ongoing that compares conventional bone imaging to 18F-sodium fluoride imaging for detecting bone metastases in cancer patients. Completion of both, the registry and the multicenter trial, are of paramount importance to achieve CMS coverage for 18F-sodium fluoride imaging PET bone imaging. The impact of these studies reaches well beyond the United States since no studies of comparable size and statistical power have been published to date. Thus, results of these trials will be relevant for the imaging community worldwide.

Around the web

Richard Heller III, MD, RSNA board member and senior VP of policy at Radiology Partners, offers an overview of policies in Congress that are directly impacting imaging.
 

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