NCT04389593已完成不适用
Comparative and Additive Diagnostic Performance of Magnetic Resonance Elastography (MRE) and Corrected-T1 (cT1) for Fibrosis and Inflammation in Nonalcoholic Steatohepatitis (NASH) Using Histology As Reference
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Accuracy of MRE and c-T1 to assess disease progress
研究概览
简要总结
This pilot study will evaluate conventional and investigational MR imaging and spectroscopic sequences and collect data to help plan more definitive future studies.
详细描述
This prospective pilot study evaluates the comparative and additive diagnostic performance of Magnetic Resonance Elastography (MRE) and corrected-T1 (cT1) for the detection and staging of fibrosis and inflammation in Nonalcoholic Steatohepatitis (NASH), using histology as the reference standard.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects of any gender and any ethnic group with known or suspected NASH
- •Subject is willing and able to complete required research procedures (screening/enrollment, clinical evaluation, safety procedures, and research MRI exam), and is willing to allow the study team to review clinical data including but not limited to other clinical radiology reports and images and clinical or research biopsy results
- •Subject has been fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) documents
- •Subject has had or is expected to have a clinical or research biopsy within 150 days of the MR exam
排除标准
- •VA subject
- •< 18 years of age
- •Subject does not have a physician and does not wish to be contacted about possible incidental findings
- •MRI contraindication(s)
- •Subject knows that she is pregnant or states she is trying to become pregnant
结局指标
主要结局
Accuracy of MRE and c-T1 to assess disease progress
时间窗: up to one year
The positive predictive value of quantitative imaging will be compared to histology for the assessment of NASH.
次要结局
未报告次要终点
研究者
Claude Sirlin
Professor
University of California, San Diego
研究点 (1)
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