Fully Automated High-Throughput Quantitative MRI of the Liver
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Confirm the accuracy (ie: bias) of the proposed CSE-MRI method in patients with liver steatosis and in patients with liver iron overload
研究概览
简要总结
The purpose of this research is to see if a new automated magnetic resonance imaging (MRI) method will be able to improve the images taken of the liver. Participants will have either known or suspected liver disease, known or suspected iron overload syndrome, or be a healthy adult. Participants will be in the research study for one day.
详细描述
The overall purpose of this work is to develop, implement and test a "single-button push", integrated combination of innovative MRI solutions to enable low-cost quantitative evaluation of chronic liver disease in less than 5 minutes of true MRI suite time. The aim is to design a reliable, low variability, fully automated, highly efficient MRI exam.
The primary objective is to demonstrate a free-breathing 2D CSE-MRI method that is robust to motion and free of bias when compared to the reference 3D CSE-MRI method.
Secondary objectives include optimization of the methods in healthy volunteers, and technical success and throughput of the single-button push exam:
- Repeatability: we will calculate the squared difference between each pair of repeated proton density fat fraction (PDFF) / R2* measurements, and will model this value including the acquisition/reconstruction method as a covariate using Generalized Estimating Equations (GEE)
- Reproducibility of the proposed method between 1.5T and 3T using the reproducibility coefficient and interclass correlation coefficient (ICC)
- Technical success of the single-push button exam (completion of exam, acceptable automated prescription as determined through radiologist evaluation, image quality, and automated analysis accuracy compared to manual analysis)
- Mean and standard deviation of total two-door suite time for the single-push button exam
Specific Aims:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligibility Criteria for Substudies 1, 2, 4, 5
- •Inclusion Criteria:
- •Age 18 years or older
排除标准
- •Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, claustrophobia, etc)
- •Pregnant or trying to become pregnant (as determined by self-report during MRI safety screening)
- •Eligibility Criteria for Substudy 3
- •Inclusion Criteria:
- •Age 7 years or older
- •Known or suspected liver iron overload
- •Known or suspected elevated liver fat
- •Exclusion Criteria:
- •Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, claustrophobia, etc)
- •Patients requiring intravenous (IV) conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the MRI will be allowed to participate as long as the following criteria are met:
- •The subject has their own prescription for the medication.
- •The informed consent process is conducted prior to the self-administration of this medication
- •They come to the research visit with a driver
- •Pregnant or trying to become pregnant (as determined by self-report during MRI safety screening)
- •Eligibility Criteria for Substudy 6
- •Inclusion Criteria:
- •Age 7 years or older
- •Scheduled for a clinical abdominal MRI exam
- •Exclusion Criteria:
- •Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, claustrophobia, etc)
- •Sedation required for MRI
- •Pregnant or trying to become pregnant (as determined by self-report during MRI safety screening)
研究组 & 干预措施
Healthy participants
70 healthy participants will be recruited, across substudies 1, 2, 4, and 5
干预措施: Non-contrast MRI with novel MRI software (Device)
Participants referred for clinical abdominal MRI
60 participants referred for clinical abdominal MRI will be recruited, to substudy 6
干预措施: Non-contrast MRI with novel MRI software (Device)
Participants with elevated levels of liver fat
30 participants with elevated levels of liver fat will be recruited, to substudy 3
干预措施: Non-contrast MRI with novel MRI software (Device)
Participants with known or suspected iron overload
30 Participants with known or suspected iron overload will be recruited, to substudy 3
干预措施: Non-contrast MRI with novel MRI software (Device)
结局指标
主要结局
Confirm the accuracy (ie: bias) of the proposed CSE-MRI method in patients with liver steatosis and in patients with liver iron overload
时间窗: 1 day (1 study visit, up to 3.5 hours)
For each liver segment, and for whole-liver PDFF and R2\* measurements, we will determine bias of CSE 2D using CSE 3D BH as the reference from Bland-Altman analysis. The range of R2\* values leading to reliable measurements of PDFF and R2\* will be determined using a two-segment piecewise linear model with the change point estimated from the data.
次要结局
- Mean and standard deviation of total two-door suite time for the single-push button exam(1 day (1 study visit, up to 3.5 hours))
- Measure the repeatability of the proposed CSE-MRI method in patients with liver steatosis and in patients with liver iron overload(1 day (1 study visit, up to 3.5 hours))
- Confirm the reproducibility of the proposed CSE-MRI method across field strengths(1 day (1 study visit, up to 3.5 hours))
- Image quality of free breathing 2D chemical shift encoded (CSE) method(1 day (1 study visit, up to 3.5 hours))
- Technical success rate of the integrated single-button push, fully automated CSE-MRI protocol in < 5 minutes of MR room time(1 day (1 study visit, up to 3.5 hours))