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New MRI dye could sharpen lesion detection

NCT ID NCT03986138

Diagnosis Sponsor: Guerbet 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested a new contrast agent called gadopiclenol for body MRI scans. 324 adults with known or suspected lesions received gadopiclenol and were compared to unenhanced MRI and a standard contrast agent. The goal was to see if gadopiclenol improves how well doctors can see lesion borders, internal structure, and contrast enhancement.

What this could mean

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

Active substance
gadopiclenol
What this could lead to
If successful, this could provide a safer or more effective contrast agent for body MRI scans, helping doctors see lesions more clearly.
What could go wrong
This is a completed Phase 3 trial, but results may not show a meaningful advantage over existing contrast agents. Safety concerns with gadolinium-based agents also remain.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

324 people

The number who actually took part.

Started

Aug 2019

Finished

Dec 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Patient presenting with known or suspected enhancing abnormality(ies) and/or lesion(s) in at least one body region based on a previous imaging procedure performed within 12 months prior to ICF signature. US patients are restricted to the breast in compliance with local approved indications of gadobutrol. Exclusion Criteria: * Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m² assessed within 1 day prior to each contrast agent administration.

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As listed by the trial registrant

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

Lesion in body region

Contacts and locations

Locations

  • Acibadem City Clinic Tokuda Hospital Sofia

    Sofia, Bulgaria

  • Axis Heilsa S de R.L. de C.V - Althian Clinical Research Management Center

    Monterrey, Mexico

  • Borys Clinic

    Kyiv, Ukraine

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Bucheon Suncheonhyang Hospital

    Gyeonggi-do, South Korea

  • CHU

    Angers, France

  • CHU Beaujon

    Clichy, France

  • Centrum Medyczne Affidea Wałbrzych

    Wałbrzych, Poland

  • Clinical Research Institute S.C.

    Estado de México, Mexico

  • Hospital Universitario y Politécnico La Fe

    Valencia, Spain

  • Hôpital Saint Louis

    Paris, France

  • Inje University Busan Paik Hospital

    Busan, South Korea

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

    Naples, Italy

  • Jagiellońskie Centrum Innowacji Sp. z o. o.

    Krakow, Poland

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

    Szolnok, Hungary

  • Klinik für Diagnostische und Interventionelle Radiologie

    Aachen, Germany

  • Korea University Anam Hospital

    Seoul, South Korea

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Somogy Megyei Kaposi Mor Oktato Korhaz

    Kaposvár, Hungary

  • St. Luke's Hospital

    Kropyvnytskyi, Ukraine

  • Szpital Uniwersytecki Nr 1 im. dr Antoniego Jurasza w Bydgoszczy

    Bydgoszcz, Poland

  • Szpital Świętego Rafała

    Krakow, Poland

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35249, United States

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • UConn Health - University of Connecticut

    Farmington, Connecticut, 06030-2802, United States

  • UT Health San Antonio

    San Antonio, Texas, 78207, United States

  • University Hospital Jena

    Jena, Germany

  • University of Missouri Health System

    Columbia, Missouri, 65212, United States

  • Universitätsklinikum Halle

    Halle, Germany

  • Universitätsklinikum des Saarlandes

    Homburg, Germany

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Poland

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