Department of Radiology, Asan Image Metrics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Clinical Research Division, National Institute of Food and Drug Safety Evaluation, MFDS, Cheong Ju, Republic of Korea.
Eur J Radiol. 2017 Oct;95:56-65. doi: 10.1016/j.ejrad.2017.07.023. Epub 2017 Aug 1.
To provide a systematic summary of total kidney volume (TKV) as an imaging biomarker in clinical trials for autosomal dominant polycystic kidney disease (ADPKD), focusing on the correlation between TKV and renal function.
A computerized literature search was performed using MEDLINE and EMBASE databases for studies that evaluated the correlation between TKV and the glomerular filtration rate (GFR) and between the TKV growth rate and GFR decline rate. A meta-analysis was performed to generate the summary correlation coefficient (r). A qualitative review was performed to evaluate the characteristics of TKV as an imaging biomarker.
Eighteen articles including a total sample size of 2835 patients were retrieved. Meta-analysis revealed substantial correlations between TKV and GFR [r, -0.520; 95% confidence interval (CI), -0.60 to -0.43] and between the TKV growth rate and GFR decline rate [r, -0.320; 95% CI, -0.54 to -0.10]. The quantitative review revealed that baseline TKV can affect the TKV growth rate and GFR decline rate, such that patients with a higher baseline TKV showed faster TKV growth and GFR decline. There was significant variability in image acquisition and analysis methods.
There were significant negative correlations between TKV and GFR as well as between TKV growth and GFR decline rates, suggesting that TKV imaging is a useful biomarker in clinical trials. However, standardization-or at least trial-specific standardization-of image acquisition and analysis techniques is required to use TKV as a reliable biomarker.
系统总结全肾体积(TKV)作为常染色体显性多囊肾病(ADPKD)临床试验中的影像学生物标志物,重点关注 TKV 与肾功能之间的相关性。
使用 MEDLINE 和 EMBASE 数据库进行计算机文献检索,评估 TKV 与肾小球滤过率(GFR)之间以及 TKV 增长率与 GFR 下降率之间相关性的研究。进行荟萃分析以生成汇总相关系数(r)。进行定性综述以评估 TKV 作为影像学生物标志物的特征。
检索到 18 篇文章,共纳入 2835 例患者。荟萃分析显示 TKV 与 GFR 之间存在显著相关性[r,-0.520;95%置信区间(CI),-0.60 至-0.43],以及 TKV 增长率与 GFR 下降率之间存在显著相关性[r,-0.320;95%CI,-0.54 至-0.10]。定量综述显示,基线 TKV 可影响 TKV 增长率和 GFR 下降率,即基线 TKV 较高的患者显示出更快的 TKV 增长和 GFR 下降。图像采集和分析方法存在显著差异。
TKV 与 GFR 以及 TKV 增长率与 GFR 下降率之间存在显著负相关,表明 TKV 成像在临床试验中是一种有用的生物标志物。然而,需要对图像采集和分析技术进行标准化(或至少是特定于试验的标准化),以便将 TKV 用作可靠的生物标志物。