Liver Micro Flow - MRI

Официальное название

Magnetic Resonance Imaging (MRI)-Based Quantification of Perfusion and Microstructure

Обзор

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.

Подробное описание

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:

1. Repeatability of confounder-corrected IVIM \[repeatability coefficient\] 2. Reproducibility of IVIM across acquisition parameters \[coefficient of reproducibility\] 3. Ability to predict histological features (fibrosis stage) of CLD \[area under the curve (AUC), optimal cutoffs, sensitivity, specificity\] 4. Determine the response to a meal challenge in patients without and with portal hypertension \[pre vs post meal change of IVIM parameters evaluated using mixed effects modeling\]

Вмешательства

• Устройство Novel MRI Software
  * Each study visit will last approximately 2 hours * The visit will include approximately 1 hour of MR imaging * Participants will be asked to fast for 5 hours prior to the research visit
• Другое Ensure Plus Nutrition Shake
  A subset of participants (N=15 with portal hypertension and N=15 without portal hypertension) from the Liver Fibrosis Cohort will be imaged in the fasted state, then exit the scanner where they will be asked to drink two Ensure Plus Nutrition shake. After a 20-minute delay, each subject will re-enter the scanner for additional imaging.

Первичные конечные точки

• Test-retest repeatability of IVIM parameters: Perfusion Fraction [Срок оценки: data collected over one hour during one study visit]
• Test-retest repeatability of IVIM parameters: Blood Velocity Standard Deviation [Срок оценки: data collected over one hour during one study visit]
• Test-retest repeatability of IVIM parameters: Diffusion Coefficient [Срок оценки: data collected over one hour during one study visit]

Вторичные конечные точки (6)

• Reproducibility of IVIM across acquisition parameters [Срок оценки: data collected over one hour during one study visit]
• Diagnostic performance for liver fibrosis: AUC [Срок оценки: data collected over one hour during one study visit]
• Diagnostic performance for liver fibrosis: Sensitivity (True Positive Rate) [Срок оценки: data collected over one hour during one study visit]
• Diagnostic performance for liver fibrosis: Specificity (True Negative Rate) [Срок оценки: data collected over one hour during one study visit]
• Response to Meal Challenge in Participants with and without Portal Hypertension [Срок оценки: data collected over one hour during one study visit (pre and post meal imaging)]
• Image Quality [Срок оценки: data collected over one hour during one study visit]

Критерии участия

Inclusion Criteria (Healthy Volunteers):

• Age 7 years or older
• Willing and able to complete study procedures

Exclusion Criteria (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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• University of Wisconsin — Madison

Идентификаторы

NCT: NCT07634939 · 2026-0346 · R01EB037002 · Protocol Version 4/14/26 · SMPH | Radiology

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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