Liver Micro Flow - MRI

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07634939
Status
Not Yet Recruiting

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Conditions

  • Liver Diseases

Eligibility Criteria

Sex
ALL
Age
7 Years - N/A
Healthy Volunteers
Accepted

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
  • 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.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
110 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Test-retest repeatability of IVIM parameters: Perfusion Fraction [ Time Frame: data collected over one hour during one study visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53792-

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