Shiroishi Mark S, Erickson Bradley J, Hu Leland S, Barboriak Daniel P, Becerra Lino, Bell Laura C, Boss Michael A, Boxerman Jerrold L, Cen Steven, Cimino Lisa, Fan Zhaoyang, Keenan Kathryn E, Kirsch John E, Ameli Nima, Nazemi Sina, Quarles C Chad, Rosen Mark A, Rodriguez Luis, Schmainda Kathleen M, Zahlmann Gudrun, Zhou Yuxiang, Obuchowski Nancy, Wu Ona
From the Department of Radiology, Keck School of Medicine, University of Southern California, Los Angeles, Calif (M.S.S., S.C., Z.F., N.A., S.N.); Department of Radiology, Mayo Clinic, Rochester, Minn (B.J.E.); Department of Radiology, Mayo Clinic, Scottsdale, Ariz (L.S.H., Y.Z.); Division of Neuroradiology, Department of Radiology, Duke University School of Medicine, Durham, NC (D.P.B.); Invicro, Needham, Mass (L.B.); Clinical Imaging Group, Genentech, South San Francisco, Calif (L.C.B.); Imaging Core Laboratory, American College of Radiology, Philadelphia, Pa (M.A.B., L.C.); Section of Neuroradiology, Department of Diagnostic Imaging, Warren Alpert Medical School of Brown University, Providence, RI (J.L.B.); National Institute of Standards and Technology, Boulder, Colo (K.E.K.); Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, 149 13th St, CNY 2301, Charlestown, MA 02129 (J.E.K., L.R., O.W.); Barrows Neurologic Institute, Phoenix, Ariz (C.C.Q.); Cancer Systems Imaging, MD Anderson Cancer Center, Houston, Tex (C.C.Q.); Department of Radiology, Division of Abdominal Imaging, Hospital of the University of Pennsylvania, Philadelphia, Pa (M.A.R.); College of Undergraduate Studies, University of Central Florida, Orlando, Fla (L.R.); Department of Biophysics, Medical College of Wisconsin, Milwaukee, Wis (K.M.S.); Independent Consultant, Basel, Switzerland (G.Z.); and Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio (N.O.).
Radiology. 2024 Dec;313(3):e232555. doi: 10.1148/radiol.232555.
The dynamic susceptibility contrast (DSC) MRI measures of relative cerebral blood volume (rCBV) play a central role in monitoring therapeutic response and disease progression in patients with gliomas. Previous investigations have demonstrated promise of using rCBV in classifying tumor grade, elucidating tumor viability after therapy, and differentiating pseudoprogression and pseudoresponse. However, the quantification and reproducibility of rCBV measurements across patients, devices, and software remain a critical barrier to routine or clinical trial use of longitudinal DSC MRI in patients with gliomas. To address this limitation, the RSNA DSC MRI Biomarker Committee of the Quantitative Imaging Biomarkers Alliance developed a Profile that defines statistics-based claims for the precision of longitudinal measurements. Although rCBV is the clinical marker of interest, the Profile focused on the reproducibility of the measured quantitative imaging biomarker, which is the area under the contrast agent concentration-time curve (AUC) normalized by the mean value of normal-appearing contralateral white matter tissue (tissue-normalized AUC values). Based on previous reports of within-subject coefficient of variation (wCV) in the tissue-normalized AUC values for enhancing gliomas (wCV = 0.31), an increase of 182% or more with respect to the baseline tissue-normalized AUC value indicates that an increase has occurred with 95% confidence. In contrast, a decrease of 64% or more with respect to baseline suggests that a decrease has occurred with 95% confidence. Similarly, an increase of 399% or more in the tissue-normalized AUC values in normal brain gray matter tissue (wCV = 0.40) suggests that an increase has occurred with 95% confidence, whereas a decrease of 80% or more with respect to baseline suggests that a decrease has occurred with 95% confidence. This article provides the rationale for these claims and the compliance activities needed to achieve these claims. Potential updates to incorporate new data based on advances in technology and clinical care in the Profile are also discussed.
动态磁敏感对比（DSC）磁共振成像（MRI）对相对脑血容量（rCBV）的测量在监测胶质瘤患者的治疗反应和疾病进展中起着核心作用。先前的研究已证明利用rCBV对肿瘤分级、阐明治疗后肿瘤活性以及区分假性进展和假性反应具有前景。然而，rCBV测量在不同患者、设备和软件之间的量化和可重复性仍是胶质瘤患者纵向DSC MRI用于常规或临床试验的关键障碍。为解决这一局限性，定量成像生物标志物联盟的RSNA DSC MRI生物标志物委员会制定了一份概况文件，该文件定义了基于统计的纵向测量精度声明。尽管rCBV是感兴趣的临床标志物，但该概况文件关注的是所测量的定量成像生物标志物的可重复性，即通过对侧正常白质组织平均值归一化的对比剂浓度-时间曲线下面积（组织归一化AUC值）。基于先前关于强化胶质瘤组织归一化AUC值的受试者内变异系数（wCV = 0.31）的报告，相对于基线组织归一化AUC值增加182%或更多表明增加具有95%的可信度。相比之下，相对于基线降低64%或更多表明降低具有95%的可信度。同样，正常脑灰质组织中组织归一化AUC值增加399%或更多（wCV = 0.40）表明增加具有95%的可信度，而相对于基线降低80%或更多表明降低具有95%的可信度。本文提供了这些声明的基本原理以及实现这些声明所需的合规活动。还讨论了根据该概况文件中技术和临床护理进展纳入新数据的潜在更新。
