IXICO Plc, London, UK; Department of Computing, Imperial College London, London, UK.
Eli Lilly and Company, Indianapolis, IN, USA.
Alzheimers Dement. 2014 Jul;10(4):430-438.e2. doi: 10.1016/j.jalz.2013.09.014.
Low HCV has recently been qualified by the European Medicines Agency as a biomarker for enrichment of clinical trials in predementia stages of Alzheimer's disease. For automated methods to meet the necessary regulatory requirements, it is essential they be standardized and their performance be well characterized.
The within-image and between-field strength reproducibility of automated hippocampal volumetry using the Learning Embeddings for Atlas Propagation (or LEAP) algorithm was assessed on 153 Alzheimer's Disease Neuroimaging Initiative subjects.
Tests/retests at 1.5 T and 3 T, and a comparison between 1.5 T and 3 T, yielded average unsigned variabilities in HCVs of 1.51%, 1.52%, and 2.68%. A small bias between field strengths (mean signed difference, 1.17%; standard deviation, 3.07%) was observed.
The measured reproducibility characteristics confirm the suitability of using automated magnetic resonance imaging analyses to assess HCVs quantitatively and to represent a fundamental characterization that is critical to meet the regulatory requirements for using hippocampal volumetry in clinical trials and health care.
最近，欧洲药品管理局将低 HCV 认证为阿尔茨海默病痴呆前阶段临床试验富集的生物标志物。为了使自动化方法满足必要的监管要求，对其进行标准化并充分描述其性能至关重要。
使用学习嵌入图谱传播（或 LEAP）算法对 153 名阿尔茨海默病神经影像学倡议（Alzheimer's Disease Neuroimaging Initiative）受试者的自动海马体积进行了图像内和场强间的可重复性测试。
1.5T 和 3T 的测试/重测，以及 1.5T 和 3T 之间的比较，得出 HCV 的平均未签名变异性为 1.51%、1.52%和 2.68%。观察到场强之间存在较小的偏差（平均有符号差异为 1.17%，标准差为 3.07%）。
所测量的可重复性特征证实了使用自动磁共振成像分析定量评估 HCV 的适用性，并代表了满足临床试验和医疗保健中使用海马体积计量学的监管要求的关键基础特征。
