title: Dynamic contrast-enhanced MRI for oncology drug development.
abstract: Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) is a promising tool for evaluating tumor vascularity, as it can provide vasculature-derived, functional, and quantitative parameters. To implement DCE-MRI parameters as biomarkers for monitoring the effect of antiangiogenic or vascular-disrupting treatment, two crucial elements of surrogate endpoint, ie, validation and qualification, should be satisfied. Although early studies have shown the accuracy and reliability of DCE-MRI parameters for evaluating treatment-driven vascular alterations, there have been an increasing number of studies demonstrating the limitations of DCE-MRI parameters as surrogate endpoints. Therefore, in order to improve the application of DCE-MRI parameters in drug development, it is necessary to establish a standardized evaluation method and to determine the correct therapeutics-oriented meaning of individual DCE-MRI parameter. In this regard, this article describes the biophysical background and data acquisition/analysis techniques of DCE-MRI while focusing on the validation and qualification issues. Specifically, the causes of disagreement and confusion encountered in the preclinical and clinical trials using DCE-MRI are presented in detail. Finally, considering these limitations, we present potential strategies to optimize implementation of DCE-MRI. J. Magn. Reson. Imaging 2016;44:251-264.
authors: Department of Radiology, Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.|Center for Bioimaging of New Drug Development, Asan Institute for Life Sciences, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors: Yu Sub
authors: YS
authors: Sung
authors: Department of Radiology, Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.|Center for Bioimaging of New Drug Development, Asan Institute for Life Sciences, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors: Bumwoo
authors: B
authors: Park
authors: Center for Bioimaging of New Drug Development, Asan Institute for Life Sciences, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors: Yoonseok
authors: Y
authors: Choi
authors: Center for Bioimaging of New Drug Development, Asan Institute for Life Sciences, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.|Department of Clinical Pharmacology and Therapeutics, Ulsan University College of Medicine, Asan Medical Center, Seoul, South Korea.
authors: Hyeong-Seok
authors: HS
authors: Lim
authors: Department of Radiology, Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.|Center for Bioimaging of New Drug Development, Asan Institute for Life Sciences, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors: Dong-Cheol
authors: DC
authors: Woo
authors: Department of Radiology, Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.|Center for Bioimaging of New Drug Development, Asan Institute for Life Sciences, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors: Kyung Won
authors: KW
authors: Kim
authors: Department of Radiology, Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.|Center for Bioimaging of New Drug Development, Asan Institute for Life Sciences, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors: Jeong Kon
authors: JK
authors: Kim
mesh_terms: D000818:Animals; D000970:Antineoplastic Agents / Q000627:therapeutic use; D003287:Contrast Media; D055808:Drug Discovery / Q000379:methods; D004353:Drug Evaluation, Preclinical / Q000379:methods; D016903:Drug Monitoring / Q000379:methods; D006801:Humans; D007089:Image Enhancement / Q000379:methods*; D008279:Magnetic Resonance Imaging / Q000379:methods*; D009369:Neoplasms / Q000000981:diagnostic imaging* / Q000188:drug therapy* / Q000473:pathology; D009389:Neovascularization, Pathologic / Q000000981:diagnostic imaging* / Q000188:drug therapy* / Q000473:pathology; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D000970:Antineoplastic Agents; D003287:Contrast Media
keywords: DCE-MRI; drug development; qualification; validation