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New MRI scan could spare liver patients from painful needle procedure

NCT ID NCT07554183

Diagnosis Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a special 4D-flow MRI can accurately measure blood flow and pressure in the liver without needing an invasive catheter. Researchers will enroll 60 adults with cirrhosis and compare MRI results to the standard pressure test. If it works, this could make diagnosis safer and more accessible for patients with portal hypertension.

What this could mean

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

Active substance
4D-flow MRI with gadolinium contrast
What this could lead to
If successful, this could provide a non-invasive way to diagnose and monitor portal hypertension, reducing the need for risky catheter procedures.
What could go wrong
This is a small, early-stage diagnostic study with only 60 participants. The MRI technique may not prove accurate enough to replace the current gold standard, 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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: Applicable to both groups : 1. Age ≥ 18 years 2. Eligible to undergo MRI examination 3. Prior clinical evaluation completed 4. Covered by a national health insurance scheme or beneficiary thereof (excluding State Medical Aid AME) 5. Patient informed and written informed consent obtained Specific to the MASLD group : 6. Indication for TIPS validated during a multidisciplinary team meeting and documented in the patient's medical record, including one of the following: * Refractory ascites * Hepatic hydrothorax * Failure of secondary prophylaxis of variceal gastrointestinal bleeding * Preemptive TIPS * Preoperative TIPS Specific to the MASLD group : 7. Past or current exposure to metabolic risk factors (overweight, obesity, type 2 diabetes mellitus, arterial hypertension, dyslipidemia) 8. Liver stiffness \> 15 kPa measured by transient elastography 9. Liver biopsy documenting steatosis with stage 3 fibrosis or cirrhosis 10. Alcohol consumption \< 20 g/day for women and \< 30 g/day for men, assessed using validated routine clinical questionnaires Exclusion Criteria: Applicable to both groups : 1. Any contraindication to MRI (cardiac pacemaker, implantable cardioverter-defibrillator, cochlear implants, intraocular metallic foreign bodies, intracranial vascular clips). 2. Prior liver transplantation. 3. Pregnancy, breastfeeding, or women of childbearing potential not using effective contraception. 4. Individual under legal guardianship or trusteeship, or unable to provide informed consent. 5. Participation in another interventional clinical study or currently within the exclusion period following a previous ongoing study. Specific to the TIPS group 6. Patients undergoing salvage TIPS placement in the setting of hemorrhagic shock. Specific to the MASLD group 7. Other etiologies of chronic liver disease, including viral hepatitis, autoimmune liver disease, or hemochromatosis

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver Fibrosis hepatic encephalopathy portal hypertension

As listed by the trial registrant

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

Cirrhosis Portal hypertension

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hôpital Pitié Salpêtrière

    Paris, 75013, France

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