March 26, 2008 - Clinicians changed the intended care of more than one in three cancer patients as the result of FDG-PET scan findings, according to a study of data from the National Oncologic PET Registry, published online March 24 in the Journal of Clinical Oncology (JCO).

The study analyzed data regarding nearly 23,000 patients contributed to the NOPR by more than 1,200 facilities nationwide providing positron emission tomography (PET) scans.

“The NOPR working group sought to measure the impact of PET findings on patient management in a manner minimally intrusive to care providers,” said Bruce Hillner, M.D., lead author for the study and professor and eminent university scholar in the Department of Internal Medicine at Virginia Commonwealth University. “This was critical for successfully collecting the large amount of data required for a robust analysis.”

Sponsored by the Academy of Molecular Imaging (AMI) and managed by the American College of Radiology (ACR) and the ACR Imaging Network (ACRIN), the NOPR was designed to collect questionnaire data from referring physicians on intended patient management before and after a FDG-PET scan.

The NOPR participating PET facility collects from referring physicians both a pre-PET questionnaire (documenting study indication, cancer type and anticipated stage, and planned management if PET were not available) and one of several post-PET questionnaires that assess the referring physician’s planned management in light of the FDG-PET findings.

Analysis of data collected found that FDG-PET is associated with a 36.5 percent change in the decision of whether or how to treat a patient’s cancer. NOPR working group co-chair R. Edward Coleman, M.D., professor of radiology and chief of the Division of Nuclear Medicine at Duke University School of Medicine and an AMI founding member, said “We were especially surprised by the impact of the PET findings on patients who were originally planned to have a biopsy. The procedure was avoided in approximately three-quarters of these patients.”

The NOPR was launched in May 2006 in response to the Center for Medicare and Medicaid Services’ (CMS) novel “Coverage with Evidence Development” policy to collect data through a clinical registry to inform the center’s FDG-PET coverage determination decisions for currently non-covered cancer indications.

Cancer types Medicare currently covers for reimbursement only through the NOPR include those of the ovary, uterus, prostate, pancreas, stomach, kidney and bladder.

NOPR has formally asked CMS to reconsider the current National Coverage decision on FDG-PET to end the data collection requirements for diagnosis, staging and restaging. Medicare will review the published data and determine the next steps related to reimbursement for PET scans now only covered through the NOPR. Barry Siegel, M.D., FACR, professor of radiology and chief of the Division of Nuclear Medicine at the Mallinckrodt Institute of Radiology at Washington University and chair of ACRIN’s PET Imaging Core Laboratory, also serves as an 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,” said Dr. Siegel.

FDG-PET, also called PET imaging or PET scan, is a test that images the function of cells to show differences between healthy tissue and diseased tissue. It uses a small amount of a radioactive chemical combined with sugar. This combination is called FDG, so the test is sometimes called an FDG-PET scan. It is used to evaluate various neurological and cardiac disorders, as well as for diagnosing, staging, and monitoring the treatment of many different cancers.

The ACR and ACRIN worked to develop the NOPR in collaboration with registry sponsor, the Academy for Molecular Imaging since CMS announced its intent to support a PET registry in January 2005. The American Society of Clinical Oncology and the Society for Nuclear Medicine also have played key roles in guiding the project’s development.

For more information: www.radiologyinfo.org, www.acr.org


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