NCT01110577已完成不适用
Inter-Center Reproducibility Study of Magnetic Resonance Imaging (MRI) for Quantification of Hepatic Fat Fraction in Diabetic and Pre-Diabetic Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Intra-class correlation coefficient (ICC) for repeated hepatic fat fraction (HFF) measurements from the LIPOQuant method
研究概览
简要总结
This study will assess the inter-center reproducibility and accuracy of hepatic fat fraction measurements using up to two MRI-based methods. The intra-class correlation coefficient (ICC) for the repeated measurements is expected to be greater than 0.6.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is able to travel to MRI centers
- •All patients have a BMI ≥27 kg/m2 at the prestudy (screening) visit
- •Patient is male or female and at least 18 years of age
- •At least 5 patients have type 2 diabetes mellitus or pre-diabetes
排除标准
- •Female patient is pregnant or has a positive pregnancy test at screening;
- •Patient has known liver disease other than fatty liver
- •Patient has a history of neoplastic disease
- •Patient is HIV positive
- •Patient has known claustrophobia or other contraindication to MRI
结局指标
主要结局
Intra-class correlation coefficient (ICC) for repeated hepatic fat fraction (HFF) measurements from the LIPOQuant method
时间窗: 28 +/- 7 days from Imaging Visit 1
次要结局
- ICC for repeated HFF measurements from the 3-point Dixon method(28 +/- 7 days from Imaging Visit 1)
研究者
相似试验
已完成
不适用
Validation Study of Physical Measurement of TophiGoutNCT00175006Takeda13
已完成
不适用
MRI to Measure Liver Fat ContentHepatitisFatty LiverNCT00594412National Institute of Allergy and Infectious Diseases (NIAID)53
已完成
不适用
Magnetic Resonance Imaging in Subjects With Gouty TophiGoutHyperuricemiaNCT00174954Takeda32
已完成
不适用
An Investigational Scan (Magnetic Resonance Elastography) in Detecting Treatment Response in Patients With Advanced Liver CancerAdvanced Adult Hepatocellular CarcinomaStage III Hepatocellular Carcinoma AJCC v8Stage IVB Hepatocellular Carcinoma AJCC v8Stage IIIA Hepatocellular Carcinoma AJCC v8Stage IIIB Hepatocellular Carcinoma AJCC v8Stage IV Hepatocellular Carcinoma AJCC v8Stage IVA Hepatocellular Carcinoma AJCC v8NCT04022746M.D. Anderson Cancer Center6
已完成
不适用
Inter-examiner Reproducibility of Clinical Examination Tests for Athletes with Longstanding Groin PainAdductor StrainsGroin InjuryIliopsoas SyndromeNCT03842826Aspetar60