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New MRI scan could replace endoscopy for liver patients

NCT ID NCT04867954

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 09, 2026 · Updated 4 times

Summary

This study is testing whether a new type of MRI (4D flow MRI) can detect dangerous veins in the stomach and esophagus of people with cirrhosis, which can cause fatal bleeding. Currently, doctors use a camera down the throat (endoscopy) to check, but that is invasive and often unnecessary. The study will involve 146 participants, including healthy volunteers and patients with cirrhosis, who will undergo MRI scans before and after a standardized meal. If the MRI proves accurate, it could offer a safer, non-invasive way to identify those at risk and start preventive treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ensure Plus® (standardized meal) and contrast agent for MRI
What this could lead to
If successful, this could provide a non-invasive way to identify patients at risk of variceal bleeding, reducing the need for regular endoscopies and potentially saving lives through earlier treatment.
What could go wrong
This is an early-stage validation study, not a treatment trial. The MRI technique may not prove accurate enough to replace endoscopy, and results may not apply to all cirrhosis patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

84 people

The number who actually took part.

Started

Oct 2021

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

For pre-clinical validation (Aim 1), a total of 21 participants will be recruited: 7 healthy volunteers, 14 patients with GEV. For clinical validation (Aim 2-4), 100 patients will be recruited from the UWHC endoscopy clinics. For Aim 5, 5 participants will be recruited from from the UWHC endoscopy clinics.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Wisconsin, Madison

    Madison, Wisconsin, 53704, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.