Liver DiseasesNCT07634939
Liver Micro Flow - MRI
An observational study of Liver Diseases, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Novel MRI Software and Ensure Plus Nutrition Shake
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2027to May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Age 7 years or older
- Willing and able to complete study procedures
- Age 7 years or older
- Willing and able to complete study procedures
- Clinical evidence of MASLD, MASH, cirrhosis or liver fibrosis
- Age 7 years or older
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- 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.
Who cannot join
- 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
Show all 21Show fewer
- They come to the research visit with a driver
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Magnetic Resonance Imaging (MRI)-Based Quantification of Perfusion and Microstructure
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.
Read the detailed description
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:
- Repeatability of confounder-corrected IVIM [repeatability coefficient]
- Reproducibility of IVIM across acquisition parameters [coefficient of reproducibility]
- Ability to predict histological features (fibrosis stage) of CLD [area under the curve (AUC), optimal cutoffs, sensitivity, specificity]
- 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]
- Conditions
- Liver Diseases
- Being tested
- Novel MRI Software, Ensure Plus Nutrition Shake
- Keywords
- MRI, IVIM, tissue perfusion, microstructure
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel MRI SoftwareDevice
Also called non-contrast MRI
- 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
Also called Meal challenge
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Novel MRI Software; Other: Ensure Plus Nutrition Shake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: data collected over one hour during one study visit
Secondary outcomes (6)
Reproducibility of IVIM across acquisition parameters
Consistency of IVIM measurements across MRI acquisition parameters (relevant parameters include: respiratory motion mitigation approach (respiratory triggered vs free-breathing), and/or spatial resolution, and/or diffusion weighting values), summarized using coefficients of reproducibility and variation.
Measured: data collected over one hour during one study visit
Diagnostic performance for liver fibrosis: AUC
Diagnostic performance for liver fibrosis: Ability of IVIM parameters to differentiate histologic stages of liver fibrosis using ROC analysis.
Measured: data collected over one hour during one study visit
Diagnostic performance for liver fibrosis: Sensitivity (True Positive Rate)
Diagnostic performance for liver fibrosis: Ability of IVIM parameters to differentiate histologic stages (for example: distinguish stages 0-1 from stages 2-4) of liver fibrosis using ROC analysis.
Measured: data collected over one hour during one study visit
Diagnostic performance for liver fibrosis: Specificity (True Negative Rate)
Diagnostic performance for liver fibrosis: Ability of IVIM parameters to differentiate histologic stages (for example: distinguish stages 0-1 from stages 2-4) of liver fibrosis using ROC analysis.
Measured: data collected over one hour during one study visit
Response to Meal Challenge in Participants with and without Portal Hypertension
Change in IVIM derived perfusion parameters before and after a standardized meal challenge in participants with and without portal hypertension, evaluated using mixed effects modeling.
Measured: data collected over one hour during one study visit (pre and post meal imaging)
Image Quality
Radiologist rated image quality using a 5 point Likert scale assessing motion, distortion, apparent SNR, and overall quality. Scored from 1-5 with higher scores meaning better quality.
Measured: data collected over one hour during one study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start15 Jan 2027 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Diego Hernando, PhD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634939
- Sponsor's protocol ID
- 2026-0346
- Other IDs
- R01EB037002, Protocol Version 9/21/26, SMPH | Radiology
- Status last verified
- Aug 2026
- First submitted
- 2 Jun 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging (MRI)-Based Quantification of Perfusion and Microstructure
- ClinicalTrials.gov ID
- NCT07634939
- Acronym / sponsor ID
- 2026-0346
- Conditions
- Liver Diseases
- Keywords
- MRI, IVIM, tissue perfusion, microstructure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Repeatability of confounder-corrected IVIM [repeatability coefficient]
- Reproducibility of IVIM across acquisition parameters [coefficient of reproducibility]
- Ability to predict histological features (fibrosis stage) of CLD [area under the curve (AUC), optimal cutoffs, sensitivity, specificity]
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Device: Novel MRI SoftwareHealthy 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. |
| Participants with CLD | – | Device: Novel MRI SoftwareParticipants 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. |
| Participants with Liver Fibrosis | – | Device: Novel MRI Software, Other: Ensure Plus Nutrition ShakeParticipants 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. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- Age 7 years or older
- Willing and able to complete study procedures
- Age 7 years or older
- Willing and able to complete study procedures
- Clinical evidence of MASLD, MASH, cirrhosis or liver fibrosis
Key exclusion criteria (21 listed)
- 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:
- Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, claustrophobia, etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel MRI SoftwareAlso: non-contrast MRI* 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 | Device | Healthy Volunteers, Participants with CLD, Participants with Liver Fibrosis |
| Ensure Plus Nutrition ShakeAlso: Meal challengeA 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. | Other | Participants with Liver Fibrosis |
Primary outcome
Test-retest repeatability of IVIM parameters: Perfusion Fraction
Time frame: 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
Time frame: 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
Time frame: 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.
6 secondary outcomes
Reproducibility of IVIM across acquisition parameters
Time frame: data collected over one hour during one study visit
Diagnostic performance for liver fibrosis: AUC
Time frame: data collected over one hour during one study visit
Diagnostic performance for liver fibrosis: Sensitivity (True Positive Rate)
Time frame: data collected over one hour during one study visit
Diagnostic performance for liver fibrosis: Specificity (True Negative Rate)
Time frame: data collected over one hour during one study visit
Response to Meal Challenge in Participants with and without Portal Hypertension
Time frame: data collected over one hour during one study visit (pre and post meal imaging)
Image Quality
Time frame: data collected over one hour during one study visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diego Hernando, PhD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radiology Study (608-282-8349, Radstudy@uwhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test-retest repeatability of IVIM parameters: Perfusion Fraction (time frame: data collected over one hour during one study visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.