Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New MRI dye could mean less gadolinium for patients

NCT ID NCT05915728

Diagnosis Sponsor: Bayer 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Updated 3 times

Summary

This study tested a new contrast agent called gadoquatrane for MRI scans of the body (excluding the brain and spine). The goal was to see if using a lower dose of gadolinium could still produce clear images. 404 adults with known or suspected health issues received two MRI scans: one with gadoquatrane and one with a standard contrast agent. Researchers compared how well each scan showed details like contrast, borders, and structure of the problem area.

What this could mean

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

Active substance
gadoquatrane (a new MRI contrast agent with lower gadolinium dose)
What this could lead to
If successful, this could lead to safer MRI scans with less gadolinium exposure for patients needing contrast-enhanced imaging of the body (excluding the brain and spine).
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The new agent must prove it works as well as current contrast agents, and lower gadolinium dose may still carry risks.

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

410 people

The number who actually took part.

Started

Jul 2023

Finished

Jun 2024

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: * Participant must be \>= 18 years of age inclusive, at the time of signing the informed consent form * Participants with a clinical indication for a contrast-enhanced MRI (including magnetic resonance angiography \[MRA\]), with any approved standard of care macrocyclic GBCA with proven efficacy, safety and tolerability in clinical routine CE-MRI/MRA (gadobutrol, gadoterate meglumine/ gadoteric acid or gadoteridol) that is used at the site for the indication, with known or suspected pathology of any body region, e.g. head and neck (except central nervous system \[CNS\]), thorax (including e.g. breast, heart, chest wall), abdomen (including e.g. liver, kidney, pancreas), pelvis (including e.g. prostate, uterus, ovaries), extremities (including upper and lower. * Participants who can undergo study-related procedures, including 2 contrast-enhanced MRI examinations (one with gadoquatrane and one with a comparator macrocyclic GBCA), as per participant and Investigator's judgement * Contraceptive use by female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of nonchildbearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method during the study intervention period (at a minimum of 24 hours after the last dose of study intervention). Exclusion Criteria: * Considered clinically unstable or has a concurrent/concomitant condition that may significantly alter image comparability between the 2 study MRIs or between study parameters (e.g. safety, pharmacokinetics \[PK\] parameters) or would not allow participation for the full planned study period, in the judgement of the investigator * Participants presenting with severe renal insufficiency, defined as an estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m\^2, derived from a serum or plasma creatinine sample obtained within 48 hours prior to the first contrast agent injection in the study * Participants with acute kidney injury (i.e., acute renal failure), regardless of eGFR * History of moderate to severe allergic-like reaction to any GBCA * Bronchial asthma considered unstable or who have had recent modification to their medical therapy * Receipt of any contrast agent \< 72 h prior to the study MRIs or planned to receive any contrast agent during the trial until 24 h +/- 4 h after the second study MRI * Planned or expected interventional diagnostic or therapeutic procedure (e.g. biopsy or surgery in the region of interest) or change in treatment (e.g. start of chemotherapy or antiangiogenic therapy, significant change in corticosteroids dose) that may significantly alter image comparability between the 2 MRIs or other study parameters (i.e. safety/adverse events \[AEs\] \[e.g. confounding AEs or safety events due to surgery or chemotherapy\], PK parameters), from the first study MRI up to 24 h after the second study MRI * Has received any investigational product within 30 days, or within 5 times half-life of the investigational product, whatever is shorter, prior to or concurrent with this study * Contraindications to the administration of macrocyclic GBCAs (depending on local product label), or history of adverse reaction to gadoquatrane * Any contraindication to MRI examinations based on institution policy and investigator's clinical judgement (e.g. some metallic implants or active implants)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Contrast enhancement in magnetic resonance imaging are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

As listed by the trial registrant

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

Contrast enhancement in magnetic resonance imaging Non-central nervous system pathology

Contacts and locations

Locations

  • AULSS N. 2 Marca Trevigiana_Ospedale di Treviso - UOC Radiologia

    Treviso, Veneto, 31100, Italy

  • Acibadem City Clinic | University Multiprofile Hospital for Active Treatment Tokuda - Radiology Department

    Sofia, 1407, Bulgaria

  • Ajou University Hospital | Radiology

    Suwon, Gyeonggi-do, 16499, South Korea

  • Akademiska sjukhuset i Uppsala

    Uppsala, Uppsala County, 751 85, Sweden

  • Azienda Ospedaliero-Universitaria Sant'Andrea - UOC Radiologia

    Rome, Lazio, 00189, Italy

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - Radiologia Diagnostica 1

    Brescia, Lombardy, 25123, Italy

  • Beijing Chaoyang Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100020, China

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730, China

  • Binali Yildirim Universitesi Mengucek Gazi EAH - Radyoloji

    Erzincan, 24100, Turkey (Türkiye)

  • Biogenix Molecular, LLC

    Miami, Florida, 33165, United States

  • Cardiff and Vale University Health Board |University Hospital of Wales - Clinical Research Facility

    Cardiff, Wales, CF14 4XW, United Kingdom

  • Centra Medyczne Medyceusz

    Lodz, 91-053, Poland

  • Centre Hospitalier Universitaire - Angers

    Angers, Pays de la Loire Region, 49933, France

  • Centre Hospitalier Universitaire de Dijon

    Dijon, 21079, France

  • Centro de Diagnostico Enrique Rossi | Departamento de Investigacion Clínica

    Ciudad Autonoma de Buenos Aire, Ciudad Auton. de Buenos Aires, C1425BEE, Argentina

  • Centrum Medycznym Gamma

    Warsaw, 01-785, Poland

  • Clinica Universitaria Reina Fabiola | Consultorios Externos

    Córdoba, Córdoba Province, X5004FHP, Argentina

  • Debreceni Egyetem Klinikai Kozpont - Onkologiai Klinika

    Debrecen, 4032, Hungary

  • Duke University School of Medicine - Early Phase Research Unit - Neurology

    Durham, North Carolina, 27710, United States

  • Fakultni nemocnice Plzen - Lochotin

    Pilsen, 32300, Czechia

  • Fakultní Thomayerova nemocnice - klinicko-farmakologická jednotka

    Praha 4 - Krc, 140 00, Czechia

  • Fakultní nemocnice Brno - Klinika radiologie a nukleární medicíny

    Brno, South Moravian, 625 00, Czechia

  • Fakultní nemocnice Ostrava - Radiodiagnostický ústav

    Ostrava, 708 00, Czechia

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168, Italy

  • Fundacion Cientifica del Sur | Centro de Lomas de Zamora - Imaging Interventionism Department

    Lomas de Zamora, Buenos Aires, Buenos Aires, B1832BRQ, Argentina

  • Hakodate Central General Hospital

    Hakodate, Hokkaido, 040-8585, Japan

  • Halo Diagnostics - Indian Wells

    Indian Wells, California, 92210, United States

  • Helios Herzzentrum Leipzig - Abteilung für diagnostische und interventionelle Radiologie

    Leipzig, Saxony, 04289, Germany

  • Helios Klinikum Berlin-Buch - Klinik für Kardiologie - Kardio MRT

    Berlin, State of Berlin, 13125, Germany

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • Hospices Civils de LYON

    Bron, Auvergne-Rhône-Alpes, 69500, France

  • Hospital of the University of Occupational and Environmental Health, Japan

    Kitakyushu, Fukuoka, 807-8556, Japan

  • Houston Methodist Hospital - Cardiology

    Houston, Texas, 77030, United States

  • Huai'an First People's Hospital, Nanjing Medical University

    Huai'an, Jiangsu, 223300, China

  • Hyogo Prefectural Nishinomiya Hospital

    Nishinomiya, Hyōgo, 662-0918, Japan

  • Hôpital Bichat Claude Bernard - Service de radiologie

    Paris, Île-de-France Region, 75018, France

  • Hôpital du Sacré-Cœur de Montréal | Radiology

    Montreal, Quebec, H4J 1C5, Canada

  • Instituto Alexander Fleming | Sede Central - Departamento de Diagnostico por Imagenes

    CABA, Ciudad Auton. de Buenos Aires, C1426, Argentina

  • Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

    Istanbul, 34098, Turkey (Türkiye)

  • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

    Istanbul, 34093, Turkey (Türkiye)

  • JCHO Kyushu Hospital

    Kitakyushu, Fukuoka, 806-8501, Japan

  • Japan Organization of Occupational Health and Safety Sanin Rosai Hospital

    Yonago, Tottori, 683-8605, Japan

  • Karolinska Universitetssjukhuset - Huddinge - Radiologi

    Stockholm, Stockholm County, 141 86, Sweden

  • Kishiwada Tokushukai Hospital

    Kishiwada, Osaka, 596-0042, Japan

  • Koc Universitesi Tip Fakultesi - Radyoloji

    Istanbul, 34010, Turkey (Türkiye)

  • Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital

    Osaka, Osaka, 534-0021, Japan

  • Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan

    Plovdiv, Plovdiv Province, 4002, Bulgaria

  • NZOZ Kendron

    Bialystok, 15-402, Poland

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office

    Kanazawa, Ishikawa-ken, 920-8650, Japan

  • National Hospital Organization Kanmon Medical Center

    Shimonoseki, Yamaguchi, 752-8510, Japan

  • Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice

    Pardubice, 530 03, Czechia

  • Nottingham University Hospital

    Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

  • Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uygulama ve Arastirma Merkezi

    Samsun, 55139, Turkey (Türkiye)

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7625, Hungary

  • Peking University First Hospital - Oncology Department

    Beijing, Beijing Municipality, 100034, China

  • Pennsylvania State University College of Medicine

    Hershey, Pennsylvania, 17033, United States

  • Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office

    Hakusan, Ishikawa-ken, 924-8588, Japan

  • Queen Elizabeth University Hospital

    Glasgow, Scotland, G51 4TF, United Kingdom

  • Sanatorio Allende | Departamento de Investigación Clínica

    Córdoba, Córdoba Province, X5000JHQ, Argentina

  • Sanatorio Otamendi | Imaging Diagnostic Center

    Ciudad Autonoma de Buenos Aire, Ciudad Auton. de Buenos Aires, C1115AAB, Argentina

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital

    Fukuoka, Fukuoka, 811-0213, Japan

  • Takamatsu Red Cross Hospital

    Takamatsu, Kagawa-ken, 760-0017, Japan

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong, 510630, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000, China

  • Trial Pharma Kft. Szeged

    Szeged, 6726, Hungary

  • UAB Hospital - Radiology

    Birmingham, Alabama, 35233, United States

  • UC Irvine Medical Center

    Orange, California, 92868, United States

  • Uniklinik Bonn / Radiologie

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Uniklinik Freiburg / Radiologie

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology Department

    Sofia, 1784, Bulgaria

  • University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD

    Sofia, Sofia City Province, 1431, Bulgaria

  • University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD

    Sofia, Sofia City Province, 1431, Bulgaria

  • University Multiprofile Hospital for Active Treatment Dr Georgi Stranski Pleven | Surgery Department

    Pleven, Pleven Province, 5809, Bulgaria

  • University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Radiology Department

    Sofia, Sofia City Province, 1431, Bulgaria

  • University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Imaging Diagnostic Department

    Plovdiv, Plovdiv Province, 4002, Bulgaria

  • University of Connecticut Health Center

    Farmington, Connecticut, 06032, United States

  • University of Missouri Hospital and Clinic - Neuroradiology

    Columbia, Missouri, 65212, United States

  • Universitätsklinikum Essen - Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie - 21197

    Essen, 45147, Germany

  • Universitätsmedizin Göttingen - Institut für Diagnostische und Interventionelle Radiologie

    Göttingen, Lower Saxony, 37075, Germany

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214, Poland

  • Všeobecná fakultní nemocnice v Praze

    Prague, 12808, Czechia

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610041, China

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009, China

More trials for these conditions

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