Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01EB037002 | U.S. NIH Grant/Contract | View source | |
| Protocol Version 4/14/26 | Other Identifier | UW Madison | |
| SMPH | Radiology | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel MRI Software | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | data collected over one hour during one study visit |
Not provided
Inclusion Criteria (Healthy Volunteers):
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:
Inclusion Criteria (Participants with CLD):
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:
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.
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:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Radiology Study | Contact | 608-282-8349 | Radstudy@uwhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Diego Hernando, PhD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
|
| 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. | 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. | 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. | 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. | 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. | data collected over one hour during one study visit |