Molecular Imaging Insight - June 2008 - (Page 7)

different cancers are now established,” the authors wrote. “These improvements are frequently statistically significant and average about 10 to 15 percent.” The push for prospective “The kinds of studies that radiologists and nuclear medicine physicians have been used to doing look at the sensitivity and specificity of diagnostic tests and are very uncommonly linked to outcomes; but it’s hard to look at outcomes when you’re only one tiny piece in the chain,” said Barry A. Siegel, MD, professor of radiology and chief of the division of nuclear medicine at the Mallinckrodt Institute of Radiology at Washington University in St. Louis. “Randomized, controlled trials are very hard to do in diagnostic imaging,” he noted. “Clinicians are reluctant to have patients participate in those trials and patients are reluctant to participate in those trials.” An effort to address the lack of prospective, randomized studies in nuclear medicine imaging was launched in November 2005, with the creation of the National Oncologic PET Registry (NOPR). (See sidebar starting on page 4.) NOPR was developed in response to the Centers for Medicare and Medicaid Services (CMS) proposal to expand coverage for positron emission tomography with F18 FDG PET to include cancers and indications not presently eligible for Medicare reimbursement. The NOPR working group is chaired by Hillner, and co-chaired by Siegel, Coleman, and Anthony F. Shields, MD, professor of medicine and oncology at the Karmanos Cancer Institute at Wayne State University in Detroit. Diagnostic findings from FDG-PET imaging changed the intended care of more than one in three cancer patients, according to a study of first-year data from NOPR, recently published in the Journal of Clinical Oncology (May 2008). The registry is still open and continues to accept patients, according to Shields. “As of late March this year, we had 75,000 patients enrolled,” he said. “We are currently running about 200 patients a day; I don’t think any of us expected that we would see this amount of participation when we began.” SNM president Alexander J. McEwan, MD, professor and chair of the department of oncology, faculty of medicine, at the University of Alberta and director of oncologic imaging at Cross Cancer Institute in Edmonton, Canada, believes that the NOPR model holds great promise as a structure for future evidencebased molecular imaging indications. “The NOPR trial has shown that you can, on a multicenter basis, collect the type of change of management leading to change of outcomes data that we have to build into imaging trials,” McEwan said. “I think as a base skeleton, with a bit more refinement depending on the complexity of procedure, we can use this model as a starting point for future evidence-based molecular imaging trials.” faculty of medicine, at the University of Alberta and director of oncologic imaging at Cross Cancer Institute in Edmonton, Canada. “For oncologists, we’re getting a much better idea of how to use this technology in patients with cancer,” McEwan said. “The NOPR study demonstrates that PET has a role in a number of cancers for which we now have evidence we didn’t have before.” To further a better understanding of the NOPR results and their meaning for clinical practice, as well as the appropriate use of PET technology in cancer imaging, McEwan said that SNM is closely working with both ASCO and the American Society for Therapeutic Radiology and Oncology (ASTRO) to develop more teaching courses for their members as well as ongoing involvement in one another’s conferences. On the basis of its research findings, NOPR has formally asked CMS to reconsider its current National Coverage Determination (NCD) on FDG-PET and requested that it provide Medicare coverage of FDG-PET for diagnosis, staging and restaging across all oncologic indications. CMS is expected to issue a formal response to the NOPR request by October this year. “The NOPR Working Group was careful to consider the impact of including or excluding in their analysis cases where the pre-PET treatment plan was already imaging,” said AMI president Timothy McCarthy, PhD, in a letter to Steve Purrough, MD, CMS director, coverage and analysis group. “Yet, even assuming that PET provided no advantages for those patients with pre-PET imaging plans, the NOPR Working Group’s ‘worst-case estimate’ [in their words] was that PET would nevertheless be associated with a major change in treatment in nearly 20 percent of patients.” “NOPR afforded oncologists and nuclear medicine physicians a unique opportunity to make PET available to Medicare beneficiaries and to improve our understanding of the role of PET in oncology practice,” said study author Barry A. Siegel, MD, professor of radiology and chief of the division of nuclear medicine at the Mallinckrodt Institute of Radiology at Washington University in St. Louis, chair of ACRIN’s PET Imaging Core Laboratory, and NOPR working group co-chair. “Based on these data, Medicare should strongly consider opening up the coverage to include diagnosis, staging and restaging for all cancers.” MolecularImaging.net June 2008 | Molecular Imaging Insight http://MolecularImaging.net

Table of Contents Feed for the Digital Edition of Molecular Imaging Insight - June 2008

Molecular Imaging Insight - June 2008 Contents NOPR: A Landmark Study Cover Story: Evidence-based Medicine Points to Wider Role for Molecular Imaging in Patient Care NOPR Delivers Evidence for Expanded PET Use in Oncology Imaging The Balancing Act Nuclear Cardiology’s Next Step Molecular Imaging Training Gaining Traction SPECT/CT’s Role in Post-Transplant Infection Imaging Clinical Study Digest : Heart Disease & Metastatic Breast, Gastric and Head & Neck Cancer

Molecular Imaging Insight - June 2008

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