Noninvasive, Quantitative Assessment of Liver Fat by MRI-PDFF as an Endpoint in NASH Trials.
Noninvasive, Quantitative Assessment of Liver Fat by MRI-PDFF as an Endpoint in NASH Trials.
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DOI：
10.1002/hep.29797
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发表时间：
2018-08
期刊：
影响因子：
--
通讯作者：
Loomba R
中科院分区：
文献类型：
--
作者：
Caussy C;Reeder SB;Sirlin CB;Loomba R
非酒精性脂肪性肝病（NAFLD）目前是全球慢性肝病最常见的病因，这种疾病的进展形式——非酒精性脂肪性肝炎（NASH），已成为肝脏移植的主要适应证之一。尽管进行了深入研究，但目前美国食品药品监督管理局（FDA）尚未批准用于治疗NASH的疗法。NASH药物研发的一个主要障碍是治疗反应评估仍然需要肝活检，这是一种侵入性操作，且解读具有主观性。因此，开发用于诊断和评估治疗反应的非侵入性、客观且定量的生物标志物存在重大未满足的需求。新出现的数据支持使用磁共振成像衍生的质子密度脂肪分数（MRI - PDFF）作为一种非侵入性、定量且准确的肝脏脂肪含量测量方法，以评估NASH试验早期阶段的治疗反应。在这篇综述中，我们将讨论在NASH早期试验中使用MRI - PDFF作为一种定量的、基于非侵入性成像的生物标志物的作用和效用，包括潜在的样本量减少。
Nonalcoholic fatty liver disease (NAFLD) is now the most common cause of chronic liver disease worldwide, and the progressive form of this condition, nonalcoholic steatohepatitis (NASH), has become one of the leading indications for liver transplant. Despite intensive investigations, there are currently no FDA approved therapies for treating NASH. A major barrier for drug development in NASH is that treatment response assessment continues to require liver biopsy, which is invasive and interpreted subjectively. Therefore, there is a major unmet need for developing non-invasive, objective and quantitative biomarkers for diagnosis and assessment of treatment response. Emerging data support the use of magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) as a non-invasive, quantitative, and accurate measure of liver fat content to assess treatment response in early-phase of NASH trials. In this review, we will discuss the role and utility, including potential sample-size reduction, of using MRI-PDFF as a quantitative and non-invasive imaging-based biomarker in early-phase NASH trials.
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影响因子：
4.4
作者：
Bonekamp, Susanne;Tang, An;Mashhood, Arian;Wolfson, Tanya;Changchien, Christopher;Middleton, Michael S.;Clark, Lisa;Gamst, Anthony;Loomba, Rohit;Sirlin, Claude B.
通讯作者：
Sirlin, Claude B.
DOI：
10.1002/hep.29639
发表时间：
2018-04
期刊：
Hepatology (Baltimore, Md.)
影响因子：
--
作者：
Caussy C;Alquiraish MH;Nguyen P;Hernandez C;Cepin S;Fortney LE;Ajmera V;Bettencourt R;Collier S;Hooker J;Sy E;Rizo E;Richards L;Sirlin CB;Loomba R
通讯作者：
Loomba R
影响因子：
3.3
作者：
Hernando, D.;Hines, C. D. G.;Yu, H.;Reeder, S. B.
通讯作者：
Reeder, S. B.
影响因子：
4.4
作者：
Hines, Catherine D. G.;Agni, Rashmi;Roen, Calista;Rowland, Ian;Hernando, Diego;Bultman, Eric;Horng, Debra;Yu, Huanzhou;Shimakawa, Ann;Brittain, Jean H.;Reeder, Scott B.
通讯作者：
Reeder, Scott B.
影响因子：
25.7
作者：
Dulai PS;Sirlin CB;Loomba R
通讯作者：
Loomba R