Liver Micro Flow - MRI

NCT07634939 | Not Yet Recruiting FDA Device

• 4 other identifiers: 2026-0346R01EB037002Protocol Version 4/14/26SMPH | Radiology
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Diseases

Keywords

MRI; IVIM; tissue perfusion; microstructure

Outcome Measures

Primary Outcomes (3)

• 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.

  data collected over one hour during one study visit

• Test-retest repeatability of IVIM parameters: Blood Velocity Standard Deviation

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

  data collected over one hour during one study visit

• Test-retest repeatability of IVIM parameters: Diffusion Coefficient

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

  data collected over one hour during one study visit

Secondary Outcomes (6)

• 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)

Study Arms (3)

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.

Device: Novel MRI Software

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.

Device: Novel MRI Software

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.

Device: Novel MRI Software; Other: Ensure Plus Nutrition Shake

Interventions

Novel MRI Software DEVICE

* 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

Also known as: non-contrast MRI

Healthy Volunteers; Participants with CLD; Participants with Liver Fibrosis

Ensure Plus Nutrition Shake OTHER

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.

Also known as: Meal challenge

Participants with Liver Fibrosis

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy volunteers, patients with chronic liver disease across the Metabolic dysfunction-associated steatoic liver disease (MASLD) spectrum, including steatosis, steatohepatitis (MASH), fibrosis, cirrhosis, and portal hypertension.

You may qualify if:

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

You may not qualify if:

• 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
• Age 7 years or older
• Willing and able to complete study procedures
• Clinical evidence of MASLD, MASH, cirrhosis or liver fibrosis
• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Diego Hernando, PhD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radiology Study

CONTACT

608-282-8349; Radstudy@uwhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)