Liver Micro Flow - MRI
ConditionLiver Diseases
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7+
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 7 years or older
Willing and able to complete study procedures
Disqualifiers
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)
The person has their own prescription for the medication.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
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 interventionA 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.
Treatment groups
110 Participants
are divided into 3 treatment groupsGroup A: Healthy Volunteers1 intervention
Group B: Participants with CLD1 intervention
Group C: Participants with Liver Fibrosis2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
data collected over one hour during one study visit2
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.
Time frame
data collected over one hour during one study visit3
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.
Time frame
data collected over one hour during one study visitSecondary outcomes
1
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.
Time frame
data collected over one hour during one study visit2
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.
Time frame
data collected over one hour during one study visit3
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.
Time frame
data collected over one hour during one study visit4
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.
Time frame
data collected over one hour during one study visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: