Magnetic Resonance Imaging (MRI)-Based Quantification of Perfusion and Microstructure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Test-retest repeatability of IVIM parameters: Perfusion Fraction
研究概览
简要总结
This study integrates and evaluates a series of novel MRI methods for quantifying blood perfusion and tissue microstructure. The proposed perfusion and microstructure measures may provide biomarkers for fibrosis, cirrhosis, portal hypertension, and response to treatment. The precision of these methods will be evaluated in 110 participants, including healthy volunteers, people with chronic liver disease (CLD), and people with liver fibrosis.
详细描述
The overall goal of this project is to develop a next-generation, confounder-corrected Intravoxel incoherent motion (IVIM)-MRI method for quantification of tissue perfusion and microstructure, and to validate this method in patients with CLD. This protocol will address these unmet needs through the following specific aims:
Aim 1: Develop and optimize confounder-corrected IVIM to enable precise quantification over the entire liver.
Aim 2: Validate the technical and clinical performance of confounder-corrected IVIM in patients with CLD.
Aim 3: Demonstrate confounder-corrected IVIM as a marker of intrahepatic vascular resistance in patients with CLD, including those with and without portal hypertension.
Primary Objectives:
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
- •(Healthy Volunteers):
- •Age 7 years or older
- •Willing and able to complete study procedures
排除标准
- •(Healthy Volunteers):
- •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)
- •Received ferumoxytol injection within previous one year (clinical or research)
- •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 person 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
- •Inclusion Criteria (Participants with CLD):
- •Age 7 years or older
- •Willing and able to complete study procedures
- •Clinical evidence of MASLD, MASH, cirrhosis or liver fibrosis
- •Exclusion Criteria (Participants with CLD):
- •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)
- •Received ferumoxytol injection within previous one year (clinical or research)
- •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 person 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
- •Inclusion Criteria (Liver Fibrosis Spectrum):
- •Age 7 years or older
- •Willing and able to complete study procedures
- •Known or suspected liver steatosis, steatohepatitis, fibrosis, cirrhosis, or portal hypertension, based on clinical imaging from the previous 6 months or histology over the previous 12 months.
- •At least N=50 will be selected based on having a clinically indicated liver biopsy
- •If taking beta blocker medication, willing to temporarily discontinue the medication for three days prior to the research visit after providing informed consent and in consultation with their treating physician.
- •Exclusion Criteria (Liver Fibrosis Spectrum):
- •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)
- •Received ferumoxytol injection within previous one year (clinical or research)
- •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 person 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
研究组 & 干预措施
Participants with Liver Fibrosis
Participants with known or suspected liver fibrosis or portal hypertension undergoing a single research visit with non contrast MRI to evaluate imaging performance across the fibrosis spectrum. A subset of participants will also undergo a standardized meal challenge with pre and post meal imaging.
干预措施: Ensure Plus Nutrition Shake (Other)
Healthy Volunteers
Healthy participants without known liver disease undergoing a single research visit with non contrast MRI to support development, optimization, and evaluation of MRI based perfusion and microstructure measurements.
干预措施: Novel MRI Software (Device)
Participants with CLD
Participants with chronic liver disease undergoing a single research visit with non contrast MRI to evaluate repeatability and reproducibility of MRI based perfusion and microstructure measurements.
干预措施: Novel MRI Software (Device)
Participants with Liver Fibrosis
Participants with known or suspected liver fibrosis or portal hypertension undergoing a single research visit with non contrast MRI to evaluate imaging performance across the fibrosis spectrum. A subset of participants will also undergo a standardized meal challenge with pre and post meal imaging.
干预措施: Novel MRI Software (Device)
结局指标
主要结局
Test-retest repeatability of IVIM parameters: Perfusion Fraction
时间窗: data collected over one hour during one study visit
Test-retest repeatability of IVIM parameters will be acquired during a single study visit, summarized using repeatability coefficients and Bland-Altman analysis.
Test-retest repeatability of IVIM parameters: Blood Velocity Standard Deviation
时间窗: data collected over one hour during one study visit
Test-retest repeatability of IVIM parameters will be acquired during a single study visit, summarized using repeatability coefficients and Bland-Altman analysis.
Test-retest repeatability of IVIM parameters: Diffusion Coefficient
时间窗: data collected over one hour during one study visit
Test-retest repeatability of IVIM parameters will be acquired during a single study visit, summarized using repeatability coefficients and Bland-Altman analysis.
次要结局
- Reproducibility of IVIM across acquisition parameters(data collected over one hour during one study visit)
- Diagnostic performance for liver fibrosis: AUC(data collected over one hour during one study visit)
- Diagnostic performance for liver fibrosis: Sensitivity (True Positive Rate)(data collected over one hour during one study visit)
- Diagnostic performance for liver fibrosis: Specificity (True Negative Rate)(data collected over one hour during one study visit)
- Response to Meal Challenge in Participants with and without Portal Hypertension(data collected over one hour during one study visit (pre and post meal imaging))
- Image Quality(data collected over one hour during one study visit)