Using advanced MRI to assess bleeding risk in liver disease patients
Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis
This study is testing a new MRI technique to see if it can help identify patients with cirrhosis who are at risk of dangerous bleeding from swollen veins in the esophagus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 146 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT04867954 on ClinicalTrials.gov |
What this trial studies
This research aims to validate non-invasive 4D flow MRI biomarkers to detect gastroesophageal varices (GEV) in patients with cirrhosis. The study will involve pre-clinical validations and diagnostic performance evaluations of the MRI technique to identify high-risk GEV, which can lead to fatal bleeding. Participants will include healthy volunteers and patients with known cirrhosis, and the study will assess the accuracy of the MRI compared to current non-invasive markers of liver disease. The goal is to improve patient triage for therapeutic interventions while minimizing unnecessary procedures.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with known cirrhosis and gastroesophageal varices scheduled for endoscopy.
Not a fit: Patients with contraindications to MRI or recent treatments for varices may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the ability to predict and manage the risk of life-threatening bleeding in patients with cirrhosis.
How similar studies have performed: While this approach is innovative, similar studies using advanced imaging techniques have shown promise in other contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for Aim 1: * Healthy volunteers: Adults (\>18 years) with no known liver pathology * Obese volunteers: Adults (\>18 years), no known liver pathology, body mass index (BMI) ≥ 35 * Patients: Adults (\>18 years) with known cirrhosis and known Gastroesophageal varices Exclusion Criteria for Aim 1: * contraindications to MRI * hypersensitivity reactions to both contrast agents * patients with recent treatment for varices with embolization, TIPS, or other endovascular treatment * patients with active GEV bleeding; known occlusive thrombus in portal vein, splenic vein, or superior mesenteric vein. * patients with large HCC with known PC involvement. Inclusion criteria for Aim 2-4: * Adults (\>18 years) with known cirrhosis Exclusion Criteria for Aim 2-4: * Contraindications to MRI * Recent treatment (\< 1 year) for varices * Known occlusive thrombus in portal vein; splenic vein, or superior mesenteric vein * Large hepatocellular carcinoma (HCC) with known PV involvement * Hypersensitivity reactions to both contrast agents * Participants requiring conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met: * The participant has their own prescription for the medication * The informed consent process is conducted prior to the self-administration of the medication. * The participant comes to the research visit with a driver. Inclusion Criteria for Aim 5: * Adults (\>18 years) with Fontan repair and diagnosed FALD Exclusion Criteria for Aim 5: * Contraindications to MRI * Recent treatment (\< 1 year) for varices * Known occlusive thrombus in portal vein; splenic vein, or superior mesenteric vein * Large hepatocellular carcinoma (HCC) with known PV involvement * Hypersensitivity reactions to both contrast agents * Participants requiring conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met: * The participant has their own prescription for the medication * The informed consent process is conducted prior to the self-administration of the medication. * The participant comes to the research visit with a driver.
Where this trial is running
Madison, Wisconsin
- University of Wisconsin, Madison — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Scott Reeder, MD, PhD — University of Wisconsin, Madison
- Study coordinator: Radiology Studies
- Email: radstudy@uwhealth.org
- Phone: 608-282-8349
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.