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The QIBA Profile for FDG PET/CT as an Imaging Biomarker Measuring Response to Cancer Therapy
Paul E Kinahan1, Eric S Perlman1, John J Sunderland1
1From the Department of Radiology, University of Washington, 1959 NE Pacific St, RR215, Box 357115, Seattle, WA 98195-7117 (P.E.K.); Perlman Advisory Group, LLC, Hillsdale, NY (E.S.P.); Department of Radiology, University of Iowa, Iowa City, Iowa (J.J.S.); Department of Radiology, University of Texas Southwestern, Dallas, Tex (R.S.); GE Healthcare, Waukesha, Wis (S.D.W.); Department of Radiology, Duke University Medical Center, Durham, NC (T.G.T.); The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University, Baltimore, Md (M.A.L.); Department of Radiology and Nuclear Medicine, Amsterdam, the Netherlands (R.B.); Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio (N.A.O.); and Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, Mo (R.L.W.).
Abstract:
The Quantitative Imaging Biomarkers Alliance (QIBA) Profile for fluorodeoxyglucose (FDG) PET/CT imaging was created by QIBA to both characterize and reduce the variability of standardized uptake values (SUVs). The Profile provides two complementary claims on the precision of SUV measurements. First, tumor glycolytic activity as reflected by the maximum SUV (SUVmax) is measurable from FDG PET/CT with a within-subject coefficient of variation of 10%-12%. Second, a measured increase in SUVmax of 39% or more, or a decrease of 28% or more, indicates that a true change has occurred with 95% confidence. Two applicable use cases are clinical trials and following individual patients in clinical practice. Other components of the Profile address the protocols and conformance standards considered necessary to achieve the performance claim. The Profile is intended for use by a broad audience; applications can range from discovery science through clinical trials to clinical practice. The goal of this report is to provide a rationale and overview of the FDG PET/CT Profile claims as well as its context, and to outline future needs and potential developments.
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