Liver Micro Flow - MRI

N/ANot Yet RecruitingNCT07634939

University of Wisconsin, Madison110 enrolled

Overview

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.

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 \[pre vs post meal change of IVIM parameters evaluated using mixed effects modeling\]

Study Type

OBSERVATIONAL

Enrollment

110

Conditions

Liver Diseases

Interventions

Novel MRI SoftwareDEVICE

* 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

Ensure Plus Nutrition ShakeOTHER

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.

Eligibility

Sex: ALLMin age: 7 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Test-retest repeatability of IVIM parameters: Perfusion Fraction

Test-retest repeatability of IVIM parameters will be acquired during a single study visit, summarized using repeatability coefficients and Bland-Altman analysis.