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New MRI dye could sharpen liver lesion detection

NCT ID NCT06596616

Diagnosis Sponsor: Icahn School of Medicine at Mount Sinai 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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a new MRI contrast agent, gadopiclenol, to the standard agent, gadoxetate, for imaging liver lesions. Researchers will enroll 23 adults with chronic liver disease or known liver lesions to see if gadopiclenol provides equal or better image quality and lesion visibility. Participants will undergo two MRI scans, one with each agent, and the images will be compared.

What this could mean

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

Active substance
gadopiclenol (a gadolinium-based contrast agent for MRI)
What this could lead to
If successful, this could show that gadopiclenol is as good as or better than the current standard for detecting liver lesions, potentially offering a new option for MRI scans.
What could go wrong
This is a small, early-phase study with only 23 participants, so results may not apply to everyone. The study compares image quality, not patient outcomes, and both agents carry a small risk of allergic reaction or kidney issues.

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

About 23 people

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

Started

Jul 2024

Expected to finish

Jan 2027

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.

Who is studied

Patients with undergoing MRI for management of chronic liver disease, liver lesions, and/or tumor treatment follow up

Ages

18 to 89 years

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: • Adult patients of both genders and all ethnic groups with clinical indication of MRI for chronic liver disease and/or focal lesion and/or tumor treatment follow-up. Exclusion criteria: * Acute renal insufficiency. * Severe chronic renal insufficiency (GFR \<30 mL/min/1.73 m2). * Age \<18y. * Unable or unwilling to give informed consent. * Contraindications for MRI (such as pacemakers, infusion pumps, pregnancy, allergy or previous adverse reactions to gadolinium contrast agents, severe claustrophobia).

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Conditions

The condition(s) this trial relates to.

liver disorder

As listed by the trial registrant

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

Liver lesion

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • BMEII

    New York, New York, 10029, United States

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