MarkVCID cerebral small vessel consortium: II. Neuroimaging protocols

神经影像学 医学 磁共振成像 痴呆 临床试验 疾病 神经科学 认知 生物标志物 重症监护医学 物理医学与康复 病理 放射科 心理学 精神科 生物化学 化学
作者
Hanzhang Lu,Amir H. Kashani,Konstantinos Arfanakis,Arvind Caprihan,Charles DeCarli,Brian T. Gold,Yang Li,Pauline Maillard,Claudia L. Satizábal,Lara Stables,Danny J.J. Wang,Roderick A. Corriveau,Herpreet Singh,Eric E. Smith,Bruce Fischl,André van der Kouwe,Kristin Schwab,Karl G. Helmer,Steven M. Greenberg
出处
期刊:Alzheimers & Dementia [Wiley]
卷期号:17 (4): 716-725 被引量:60
标识
DOI:10.1002/alz.12216
摘要

Abstract The MarkVCID consortium was formed under cooperative agreements with the National Institute of Neurologic Diseases and Stroke (NINDS) and National Institute on Aging (NIA) in 2016 with the goals of developing and validating biomarkers for the cerebral small vessel diseases associated with the vascular contributions to cognitive impairment and dementia (VCID). Rigorously validated biomarkers have consistently been identified as crucial for multicenter studies to identify effective strategies to prevent and treat VCID, specifically to detect increased VCID risk, diagnose the presence of small vessel disease and its subtypes, assess prognosis for disease progression or response to treatment, demonstrate target engagement or mechanism of action for candidate interventions, and monitor disease progression during treatment. The seven project sites and central coordinating center comprising MarkVCID, working with NINDS and NIA, identified a panel of 11 candidate fluid‐ and neuroimaging‐based biomarker kits and established harmonized multicenter study protocols (see companion paper “MarkVCID cerebral small vessel consortium: I. Enrollment, clinical, fluid protocols” for full details). Here we describe the MarkVCID neuroimaging protocols with specific focus on validating their application to future multicenter trials. MarkVCID procedures for participant enrollment; clinical and cognitive evaluation; and collection, handling, and instrumental validation of fluid samples are described in detail in a companion paper. Magnetic resonance imaging (MRI) has long served as the neuroimaging modality of choice for cerebral small vessel disease and VCID because of its sensitivity to a wide range of brain properties, including small structural lesions, connectivity, and cerebrovascular physiology. Despite MRI's widespread use in the VCID field, there have been relatively scant data validating the repeatability and reproducibility of MRI‐based biomarkers across raters, scanner types, and time intervals (collectively defined as instrumental validity). The MRI protocols described here address the core MRI sequences for assessing cerebral small vessel disease in future research studies, specific sequence parameters for use across various research scanner types, and rigorous procedures for determining instrumental validity. Another candidate neuroimaging modality considered by MarkVCID is optical coherence tomography angiography (OCTA), a non‐invasive technique for directly visualizing retinal capillaries as a marker of the cerebral capillaries. OCTA has theoretical promise as a unique opportunity to visualize small vessels derived from the cerebral circulation, but at a considerably earlier stage of development than MRI. The additional OCTA protocols described here address procedures for determining OCTA instrumental validity, evaluating sources of variability such as pupil dilation, and handling data to maintain participant privacy. MRI protocol and instrumental validation The core sequences selected for the MarkVCID MRI protocol are three‐dimensional T1‐weighted multi‐echo magnetization‐prepared rapid‐acquisition‐of‐gradient‐echo (ME‐MPRAGE), three‐dimensional T2‐weighted fast spin echo fluid‐attenuated‐inversion‐recovery (FLAIR), two‐dimensional diffusion‐weighted spin‐echo echo‐planar imaging (DWI), three‐dimensional T2*‐weighted multi‐echo gradient echo (3D‐GRE), three‐dimensional T 2 ‐weighted fast spin‐echo imaging (T2w), and two‐dimensional T2*‐weighted gradient echo echo‐planar blood‐oxygenation‐level‐dependent imaging with brief periods of CO 2 inhalation (BOLD‐CVR). Harmonized parameters for each of these core sequences were developed for four 3 Tesla MRI scanner models in widespread use at academic medical centers. MarkVCID project sites are trained and certified for their instantiation of the consortium MRI protocols. Sites are required to perform image quality checks every 2 months using the Alzheimer's Disease Neuroimaging Initiative phantom. Instrumental validation for MarkVCID MRI‐based biomarkers is operationally defined as inter‐rater reliability, test‐retest repeatability, and inter‐scanner reproducibility. Assessments of these instrumental properties are performed on individuals representing a range of cerebral small vessel disease from mild to severe. Inter‐rater reliability is determined by distribution of an independent dataset of MRI scans to each analysis site. Test‐retest repeatability is determined by repeat MRI scans performed on individual participants on a single MRI scanner after a short (1‐ to 14‐day) interval. Inter‐scanner reproducibility is determined by repeat MRI scans performed on individuals performed across four MRI scanner models. OCTA protocol and instrumental validation The MarkVCID OCTA protocol uses a commercially available, Food and Drug Administration‐approved OCTA apparatus. Imaging is performed on one dilated and one undilated eye to assess the need for dilation. Scans are performed in quadruplicate. MarkVCID project sites participating in OCTA validation are trained and certified by this biomarker's lead investigator. Inter‐rater reliability for OCTA is assessed by distribution of OCTA datasets to each analysis site. Test‐retest repeatability is assessed by repeat OCTA imaging on individuals on the same day as their baseline OCTA and a different‐day repeat session after a short (1‐ to 14‐day) interval. Methods were developed to allow the OCTA data to be de‐identified by the sites before transmission to the central data management system. The MarkVCID neuroimaging protocols, like the other MarkVCID procedures, are designed to allow translation to multicenter trials and as a template for outside groups to generate directly comparable neuroimaging data. The MarkVCID neuroimaging protocols are available to the biomedical community and intended to be shared. In addition to the instrumental validation procedures described here, each of the neuroimaging MarkVCID kits will undergo biological validation to determine its ability to measure important aspects of VCID such as cognitive function. The analytic methods for the neuroimaging‐based kits and the results of these validation studies will be published separately. The results will ultimately determine the neuroimaging kits’ potential usefulness for multicenter interventional trials in small vessel disease–related VCID.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
2秒前
潇湘雪月发布了新的文献求助10
2秒前
4秒前
6秒前
大模型应助hello采纳,获得10
6秒前
我爱学习发布了新的文献求助10
6秒前
酷波er应助忐忑的阑香采纳,获得10
7秒前
8秒前
如意枫叶发布了新的文献求助10
9秒前
无花果应助猪猪hero采纳,获得10
14秒前
亮liang发布了新的文献求助10
14秒前
cach完成签到,获得积分10
14秒前
量子星尘发布了新的文献求助10
15秒前
棣棣完成签到,获得积分10
15秒前
Paris7k完成签到 ,获得积分10
15秒前
糊涂涂完成签到,获得积分20
16秒前
大个应助Yang采纳,获得10
17秒前
18秒前
王伟涛完成签到,获得积分10
18秒前
20秒前
CipherSage应助如意枫叶采纳,获得10
23秒前
潇湘雪月发布了新的文献求助10
23秒前
斯文败类应助依依采纳,获得10
24秒前
华仔应助健康的老六采纳,获得10
24秒前
24秒前
JamesPei应助豪的花花采纳,获得50
24秒前
CSPC001发布了新的文献求助10
25秒前
26秒前
完美小蘑菇应助hp采纳,获得10
27秒前
hello发布了新的文献求助10
28秒前
31秒前
wwwstt发布了新的文献求助10
32秒前
CodeCraft应助过氧化氢采纳,获得10
34秒前
如意枫叶发布了新的文献求助10
35秒前
面壁思过应助m7m采纳,获得30
37秒前
37秒前
大模型应助猪猪hero采纳,获得10
37秒前
38秒前
FashionBoy应助科研通管家采纳,获得10
38秒前
CodeCraft应助科研通管家采纳,获得10
38秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3989242
求助须知:如何正确求助?哪些是违规求助? 3531393
关于积分的说明 11253753
捐赠科研通 3270010
什么是DOI,文献DOI怎么找? 1804868
邀请新用户注册赠送积分活动 882084
科研通“疑难数据库(出版商)”最低求助积分说明 809136