A medical device-grade T1 and ECV phantom for global T1 mapping quality assurance-the T(1) Mapping and ECV Standardization in cardiovascular magnetic resonance (T1MES) program.
A medical device-grade T1 and ECV phantom for global T1 mapping quality assurance-the T(1) Mapping and ECV Standardization in cardiovascular magnetic resonance (T1MES) program.
复制标题
DOI：
10.1186/s12968-016-0280-z
复制
发表时间：
2016-09-22
期刊：
影响因子：
--
通讯作者：
Moon JC
中科院分区：
文献类型：
--
作者：
Captur G;Gatehouse P;Keenan KE;Heslinga FG;Bruehl R;Prothmann M;Graves MJ;Eames RJ;Torlasco C;Benedetti G;Donovan J;Ittermann B;Boubertakh R;Bathgate A;Royet C;Pang W;Nezafat R;Salerno M;Kellman P;Moon JC
T1标测和细胞外容积（ECV）有可能指导患者护理，并在临床试验中作为替代终点，但心血管磁共振（CMR）扫描仪和脉冲序列之间的测量结果不同。为了帮助向全球临床护理提供T1标测，我们开发了一种基于体模的质量保证（QA）系统，用于验证各个站点随时间推移的测量稳定性，进一步的目标是跨站点、供应商系统、软件版本和成像序列推广结果。因此，我们创建了T1 MES：T1映射和ECV标准化程序。一个由专业的MRI中小型企业、临床医生、物理学家和国家计量机构组成的设计合作已经形成。设计了一个体模，覆盖了1.5 T和3 T造影前后血液和心肌中T1和T2的临床相关范围。建立了可重复的大规模生产。该器械获得了美国食品药品监督管理局（FDA）的监管许可，并获得了符合欧洲标准（CE）标志。T1 MES体模是一种琼脂糖凝胶体模，使用氯化镍作为顺磁弛豫改性剂。它是可重复的指定和大规模生产的严格可重复的过程。每个体模包含9个不同掺杂的琼脂糖凝胶管，包埋在凝胶/珠基质中。在两种场强下，MRI均无气泡和磁化率伪影，T1标测图无非共振伪影。在主凝胶填充物中掺入高密度聚乙烯珠可有效地使B1场变平。在T1 MES中测量的T1和T2值显示重复扫描之间的变异系数为1%或更小，表明短期重现性良好。温度依赖性实验证实，在15-30 °C的范围内，短T1管比长T1管对温度更稳定。批量生产了一批69个体模，其中10个体模随机抽样，在1.5 T和3 T下T1的变异系数分别为0.64 ± 0.45%和0.49 ± 0.34%。T1 MES项目已开发出符合CE/FDA制造标准的T1标测体模。最初的69个带有多供应商用户手册的幻影现在每两周在世界各地的中心进行扫描。未来的结果将探索T1定位序列、平台性能、稳定性和标准化的潜力。本文的在线版本（doi：10.1186/s12968-016-0280-z）包含补充材料，可供授权用户使用。
T1 mapping and extracellular volume (ECV) have the potential to guide patient care and serve as surrogate end-points in clinical trials, but measurements differ between cardiovascular magnetic resonance (CMR) scanners and pulse sequences. To help deliver T1 mapping to global clinical care, we developed a phantom-based quality assurance (QA) system for verification of measurement stability over time at individual sites, with further aims of generalization of results across sites, vendor systems, software versions and imaging sequences. We thus created T1MES: The T1 Mapping and ECV Standardization Program. A design collaboration consisting of a specialist MRI small-medium enterprise, clinicians, physicists and national metrology institutes was formed. A phantom was designed covering clinically relevant ranges of T1 and T2 in blood and myocardium, pre and post-contrast, for 1.5 T and 3 T. Reproducible mass manufacture was established. The device received regulatory clearance by the Food and Drug Administration (FDA) and Conformité Européene (CE) marking. The T1MES phantom is an agarose gel-based phantom using nickel chloride as the paramagnetic relaxation modifier. It was reproducibly specified and mass-produced with a rigorously repeatable process. Each phantom contains nine differently-doped agarose gel tubes embedded in a gel/beads matrix. Phantoms were free of air bubbles and susceptibility artifacts at both field strengths and T1 maps were free from off-resonance artifacts. The incorporation of high-density polyethylene beads in the main gel fill was effective at flattening the B1 field. T1 and T2 values measured in T1MES showed coefficients of variation of 1 % or less between repeat scans indicating good short-term reproducibility. Temperature dependency experiments confirmed that over the range 15–30 °C the short-T1 tubes were more stable with temperature than the long-T1 tubes. A batch of 69 phantoms was mass-produced with random sampling of ten of these showing coefficients of variations for T1 of 0.64 ± 0.45 % and 0.49 ± 0.34 % at 1.5 T and 3 T respectively. The T1MES program has developed a T1 mapping phantom to CE/FDA manufacturing standards. An initial 69 phantoms with a multi-vendor user manual are now being scanned fortnightly in centers worldwide. Future results will explore T1 mapping sequences, platform performance, stability and the potential for standardization. The online version of this article (doi:10.1186/s12968-016-0280-z) contains supplementary material, which is available to authorized users.
登录
查看更多内容
影响因子：
3.3
作者：
Gai, Neville D.;Stehning, Christian;Bluemke, David A.
通讯作者：
Bluemke, David A.
影响因子：
1.3
作者：
CHRISTOFFERSSON, JO;OLSSON, LE;SJOBERG, S
通讯作者：
SJOBERG, S
DOI：
10.1002/0470869526.ch3
发表时间：
2003-01-01
期刊：
QUANTITATIVE MRI OF THE BRAIN: MEASURING CHANGES CAUSED BY DISEASE
影响因子：
--
作者：
Tofts, Paul S.
通讯作者：
Tofts, Paul S.
影响因子：
3.3
作者：
KOENIG, SH;BROWN, RD
通讯作者：
BROWN, RD
DOI：
10.1186/1532-429x-15-64
发表时间：
2013-07-26
期刊：
Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance
影响因子：
--
作者：
Raman FS;Kawel-Boehm N;Gai N;Freed M;Han J;Liu CY;Lima JA;Bluemke DA;Liu S
通讯作者：
Liu S