RESTON, Va.--Publication of consensus recommendations for the use of positron emission tomography (PET) imaging--with the radiotracer fluorodeoxyglucose (FDG)--in National Cancer Institute trials will go a long way in helping physicians and scientists determine ways to manage cancer and promote drug development in the future. The recommendations, published in the June issue of the Journal of Nuclear Medicine, focus on the practical aspects of FDG PET (patient preparation; image acquisition, reconstruction and analysis; and quality assurance) and provide a valuable reference for incorporating PET into clinical trials.


"There should be less variability in the performance of FDG PET in clinical trials by enacting these recommendations," explained principal author Lalitha K. Shankar, NCI medical officer at the Cancer Imaging Program. "This would help speed the evaluation of FDG PET as a biomarker. If FDG PET, as is hoped, proves to be a useful biomarker in certain cancers--such as lymphoma, lung and breast cancer among others--this could potentially result in be shorter clinical trials in these malignancies and improved therapy for patients with these cancers," she said. These guidelines, drafted by PET experts at various universities and institutes in the United States and abroad, represent a step toward qualifying FDG PET as a biomarker or biologic indicator to assess cancer treatment response.



"To date, there has been no significant agreement on the best methodology for obtaining or analyzing 18F-FDG PET. Standard protocols needed to be developed so that data about the effectiveness of FDG PET as an indicator of treatment response in patients could be collected and compared," Shankar added. Publication of the consensus recommendations is the culmination of attempts to reach agreement between physician and scientist members of the imaging community on certain basic issues regarding the acquisition and analysis of these scans, she said.


The recommendations are the result of a workshop sponsored by NCI's Cancer Imaging Program in Washington, D.C., in 2005. Participants reviewed the status of FDG PET technology and clinical experience in both diagnosis and in monitoring therapeutic response. More recently, NCI, the U.S. Food and Drug Administration and the Centers for Medicare and Medicaid Services entered into a memo of understanding to improve "the clinical utility of biomarker technologies as diagnostic and assessment tools that facilitate the development of safer and more effective cancer therapies."

More Industry Headlines