A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except Brain or Spinal Cord-related Problems)

Last updated: June 12, 2024
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

Gadoteridol

Gadoterate meglumine

Gadoquatrane (BAY1747846)

Clinical Study ID

NCT05915728
21197
2022-501885-24-00
  • Ages > 18
  • All Genders

Study Summary

Researchers are looking for a better way to help people with any known or suspected problems (except brain or spinal cord-related problems) scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).

MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.

The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.

The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect known or suspected problems (except brain or spinal cord-related problems) with gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.

The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.

Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.

At the start or during the study, the doctors and their study team will:

  • take blood and urine samples

  • do physical examinations

  • check blood pressure and heart rate

  • review the MRI scans obtained in the study and decide on the diagnosis

  • ask the participants questions about how they are feeling and what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be >= 18 years of age inclusive, at the time of signing theinformed consent form

  • Participants with a clinical indication for a contrast-enhanced MRI (includingmagnetic resonance angiography [MRA]), with any approved standard of caremacrocyclic GBCA with proven efficacy, safety and tolerability in clinical routineCE-MRI/MRA (gadobutrol, gadoterate meglumine/ gadoteric acid or gadoteridol) that isused at the site for the indication, with known or suspected pathology of any bodyregion, e.g. head and neck (except central nervous system [CNS]), thorax (includinge.g. breast, heart, chest wall), abdomen (including e.g. liver, kidney, pancreas),pelvis (including e.g. prostate, uterus, ovaries), extremities (including upper andlower.

  • Participants who can undergo study-related procedures, including 2 contrast-enhancedMRI 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 regulationsregarding the methods of contraception for those participating in clinical studies.A female participant is eligible to participate if she is not pregnant orbreastfeeding, and one of the following conditions applies: Is a woman ofnonchildbearing 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

Exclusion Criteria:

  • Considered clinically unstable or has a concurrent/concomitant condition that maysignificantly alter image comparability between the 2 study MRIs or between studyparameters (e.g. safety, pharmacokinetics [PK] parameters) or would not allowparticipation for the full planned study period, in the judgement of theinvestigator

  • Participants presenting with severe renal insufficiency, defined as an estimatedglomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2, derived from a serum orplasma creatinine sample obtained within 48 hours prior to the first contrast agentinjection in the study

  • Participants with acute kidney injury (i.e., acute renal failure), regardless ofeGFR

  • History of moderate to severe allergic-like reaction to any GBCA

  • Bronchial asthma considered unstable or who have had recent modification to theirmedical therapy

  • Receipt of any contrast agent < 72 h prior to the study MRIs or planned to receiveany 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. biopsyor surgery in the region of interest) or change in treatment (e.g. start ofchemotherapy or antiangiogenic therapy, significant change in corticosteroids dose)that may significantly alter image comparability between the 2 MRIs or other studyparameters (i.e. safety/adverse events [AEs] [e.g. confounding AEs or safety eventsdue to surgery or chemotherapy], PK parameters), from the first study MRI up to 24 hafter the second study MRI

  • Has received any investigational product within 30 days, or within 5 times half-lifeof the investigational product, whatever is shorter, prior to or concurrent withthis study

  • Contraindications to the administration of macrocyclic GBCAs (depending on localproduct label), or history of adverse reaction to gadoquatrane

  • Any contraindication to MRI examinations based on institution policy andinvestigator's clinical judgement (e.g. some metallic implants or active implants)

Study Design

Total Participants: 404
Treatment Group(s): 4
Primary Treatment: Gadoteridol
Phase: 3
Study Start date:
July 24, 2023
Estimated Completion Date:
June 01, 2024

Connect with a study center

  • Fundacion Cientifica del Sur

    Lomas De Zamora, Buenos Aires, Buenos Aires B1832BRQ
    Argentina

    Site Not Available

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

    Lomas De Zamora, Buenos Aires, Buenos Aires B1832BRQ
    Argentina

    Site Not Available

  • Fundacion Cientifica del Sur

    Lornas De Zamora, Buenos Aires B1832BQS
    Argentina

    Site Not Available

  • Centro de Diagnóstico Dr. Enrique Rossi

    Buenos Aires, Ciudad Auton. De Buenos Aires C1425BEE
    Argentina

    Site Not Available

  • Sanatorio Otamendi

    Buenos Aires, Ciudad Auton. De Buenos Aires C1115AAB
    Argentina

    Active - Recruiting

  • Sanatorio Otamendi | Imaging Diagnostic Center

    Buenos Aires, Ciudad Auton. De Buenos Aires C1115AAB
    Argentina

    Site Not Available

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

    Caba, Ciudad Auton. De Buenos Aires C1426
    Argentina

    Site Not Available

  • Instituto Medico Especializado Alexander Fleming

    Caba, Ciudad Auton. De Buenos Aires C1426
    Argentina

    Site Not Available

  • Clinica Universitaria Reina Fabiola | Consultorios Externos

    Cordoba, Córdoba X5004FHP
    Argentina

    Site Not Available

  • Clinica Universitaria Reina Fabiola | Consultorios Externos

    Córdoba, X5004FHP
    Argentina

    Active - Recruiting

  • Clínica Universitaria Reina Fabiola

    Córdoba, X5004FHP
    Argentina

    Site Not Available

  • Sanatorio Allende | Departamento de Investigación Clínica

    Córdoba, X5000JHQ
    Argentina

    Site Not Available

  • UMHAT Dr. Georgi Stranski

    Pleven, 5800
    Bulgaria

    Site Not Available

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

    Pleven, 5800
    Bulgaria

    Site Not Available

  • MHAT Central Onco Hospital

    Plovdiv, 4002
    Bulgaria

    Site Not Available

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

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • UMHAT Sveti Georgi

    Plovdiv, 4000
    Bulgaria

    Site Not Available

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

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • Acibadem City Clinic Multiprofile Hospital for Active Treatm

    Sofia, 1407
    Bulgaria

    Site Not Available

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

    Sofia, 1407
    Bulgaria

    Site Not Available

  • UMHAT Alexandrovska EAD

    Sofia, 1431
    Bulgaria

    Site Not Available

  • UMHAT Prof. Dr Aleksandar Chirkov

    Sofia, 1431
    Bulgaria

    Active - Recruiting

  • UMHAT Tsaritsa Yoanna-ISUL Clinic of imaging diagnostic

    Sofia, 1527
    Bulgaria

    Site Not Available

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

    Sofia, 1784
    Bulgaria

    Site Not Available

  • University Multiprofile Hosp. for Active Treat. Sveti Ivan

    Sofia, 1431
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment Prof. Dr. Alexander Chirkov EAD

    Sofia, 1431
    Bulgaria

    Site Not Available

  • St.Joseph's Health Care-London

    London, Ontario N6G 2M3
    Canada

    Site Not Available

  • Princess Margaret Hospital-University Health Network

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Toronto General Hospital UHN

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec QC H4J 1C5
    Canada

    Site Not Available

  • London Health Sciences Centre (LHSC) - University Hospital

    London, N6A 5A5
    Canada

    Site Not Available

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong 510630
    China

    Site Not Available

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

    Huai'An, Jiangsu 223300
    China

    Site Not Available

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu 210009
    China

    Site Not Available

  • West China Hospital Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

  • Beijing Chaoyang Hospital, Capital Medical University

    Beijing, 100020
    China

    Site Not Available

  • Beijing Hospital

    Beijing, 100730
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, 100034
    China

    Site Not Available

  • Fakultni nemocnice Brno

    Brno, 625 00
    Czechia

    Site Not Available

  • Fakultni nemocnice Ostrava

    Ostrava, 708 52
    Czechia

    Site Not Available

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

    Pardubice, 530 03
    Czechia

    Site Not Available

  • Fakultni nemocnice Plzen - Lochotin

    Plzen, 32300
    Czechia

    Site Not Available

  • Fakultni nemocnice Plzen - Lochotin

    Plzen-Lochotin, 323 00
    Czechia

    Site Not Available

  • Fakultni Thomayerova Nemocnice

    Prague, 140 59
    Czechia

    Site Not Available

  • Vseobecna fakultni nemocnice v Praze

    Praha 2, 12808
    Czechia

    Site Not Available

  • Fakultni Thomayerova Nemocnice

    Praha 4, 140 59
    Czechia

    Site Not Available

  • Centre Hospitalier Universitaire - Angers

    Angers, 49933
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Dijon

    Dijon, 21079
    France

    Site Not Available

  • Hôpital Général - Dijon

    Dijon, 21033
    France

    Site Not Available

  • Hospices Civils de LYON

    Lyon, 69229
    France

    Site Not Available

  • Hopital Bichat - Paris

    Paris, 75018
    France

    Site Not Available

  • Uniklinik Freiburg / Radiologie

    Freiburg, Baden-Württemberg 79106
    Germany

    Site Not Available

  • Universitätsmed Göttingen Institut f. Diag&Interv Radiologie

    Göttingen, Niedersachsen 37075
    Germany

    Site Not Available

  • Uniklinik Bonn / Radiologie

    Bonn, Nordrhein-Westfalen 53127
    Germany

    Site Not Available

  • Helios Herzzentrum Leipzig - Abteilung für Radiologie

    Leipzig, Sachsen 04289
    Germany

    Site Not Available

  • Universitätsklinikum Aachen / Klinik für Diagnostische und Interventionelle Radiologie

    Aachen, 52074
    Germany

    Site Not Available

  • HELIOS Klinikum Berlin - Buch

    Berlin, 13125
    Germany

    Site Not Available

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

    Essen, 45147
    Germany

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

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  • Flor Ferenc Korhaz

    Kistarcsa, 2143
    Hungary

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  • Kistarcsai Flor Ferenc Korhaz

    Kistarcsa, 2143
    Hungary

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  • BAZMKK es EOK, Kozponti Diagnosztikai Centrum

    Miskolc, 3526
    Hungary

    Site Not Available

  • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz, Kozponti Diagnosztikai Centrum

    Miskolc, 3526
    Hungary

    Site Not Available

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pecs, 7625
    Hungary

    Site Not Available

  • Trial Pharma Kft. Szeged

    Szeged, 6726
    Hungary

    Site Not Available

  • A.O.U. Sant'Andrea

    Roma, Lazio 00189
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, Lazio 00168
    Italy

    Site Not Available

  • ASST Spedali Civili di Brescia

    Brescia, Lombardia 25123
    Italy

    Site Not Available

  • Ospedale San Raffaele s.r.l.

    Milano, Lombardia 20132
    Italy

    Site Not Available

  • ULSS2 Marca Trevigiana

    Treviso, Veneto 31100
    Italy

    Site Not Available

  • Nagoya Tokushukai Genaral Hospital

    Kasugai, Aichi 487-0016
    Japan

    Site Not Available

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

    Kitakyushu, Fukuoka 807-8556
    Japan

    Site Not Available

  • JCHO Kyushu Hospital

    Kitakyushu, Fukuoka 806-8501
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo, Hokkaido 060-8648
    Japan

    Site Not Available

  • Hyogo Prefectural Nishinomiya Hospital

    Nishinomiya, Hyogo 662-0918
    Japan

    Site Not Available

  • Public Central Hospital of Matto Ishikawa

    Hakusan, Ishikawa 924-8588
    Japan

    Active - Recruiting

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

    Hakusan, Ishikawa 924-8588
    Japan

    Site Not Available

  • National Hospital Organization Kanazawa Medical Center

    Kanazawa, Ishikawa 920-8650
    Japan

    Active - Recruiting

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

    Kanazawa, Ishikawa 920-8650
    Japan

    Site Not Available

  • Takamatsu Red Cross Hospital

    Takamatsu, Kagawa 760-0017
    Japan

    Site Not Available

  • Kishiwada Tokushukai Hospital

    Kishiwada, Osaka 596-0042
    Japan

    Site Not Available

  • Japan Organization of Occupational Health and Safety Sanin Rosai Hospital

    Yonago, Tottori 683-8605
    Japan

    Site Not Available

  • National Hospital Organization Kanmon Medical Center

    Shimonoseki, Yamaguchi 752-8510
    Japan

    Site Not Available

  • Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital

    Fukuoka, 811-0213
    Japan

    Site Not Available

  • Hakodate Central General Hospital

    Hakodate, 040-8585
    Japan

    Site Not Available

  • Hanyu General Hospital

    Hanyu, 348-8505
    Japan

    Site Not Available

  • Osaka City General Hospital

    Osaka, 534-0021
    Japan

    Site Not Available

  • Ajou University Hospital

    Suwon, Gyeonggido 443-721
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, Seoul Teugbyeolsi 138-736
    Korea, Republic of

    Site Not Available

  • Konkuk University Medical Center

    Seoul, Seoul Teugbyeolsi 5030
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi 3080
    Korea, Republic of

    Site Not Available

  • Inje University Busan Paik Hospital

    Busan, 47392
    Korea, Republic of

    Site Not Available

  • NZOZ Kendron

    Bialystok, 15-402
    Poland

    Site Not Available

  • NZOZ Kendron

    Białystok,
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214
    Poland

    Site Not Available

  • Centra Medyczne Medyceusz

    Lodz, 91-053
    Poland

    Site Not Available

  • Centrum Medyczne HCP Sp. z o.o.

    Poznan, 61-485
    Poland

    Site Not Available

  • Centrum Medycznym Gamma

    Warszawa, 01-785
    Poland

    Site Not Available

  • Karolinska University Hospital Huddinge Radiology

    Stockholm, 14186
    Sweden

    Site Not Available

  • Akademiska Sjukhuset

    Uppsala, 751 85
    Sweden

    Site Not Available

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City, 23561
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Site Not Available

  • Chi Mei Medical Center - Medical Imaging Department

    Tainan, 71004
    Taiwan

    Site Not Available

  • Taipei Medical University Hospital - Medical Imaging department

    Taipei, 110
    Taiwan

    Site Not Available

  • Taipei Municipal Wanfang Hospital

    Taipei, 116
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei City, 114
    Taiwan

    Site Not Available

  • Lokman Hekim Universitesi Tip Fakultesi - Radyoloji

    Ankara, 06510
    Turkey

    Site Not Available

  • Binali Yildirim Universitesi Mengucek Gazi EAH - Radyoloji

    Erzincan, 24610
    Turkey

    Site Not Available

  • Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

    Istanbul, 34098
    Turkey

    Site Not Available

  • Istanbul Universitesi Istanbul Tip Fakultesi

    Istanbul, 34093
    Turkey

    Site Not Available

  • Koc Universitesi Tip Fakultesi - Radyoloji

    Istanbul, 34010
    Turkey

    Site Not Available

  • Ondokuz Mayis Uni Tip Fakultesi

    Samsun, 55139
    Turkey

    Site Not Available

  • Queen Elizabeth University Hospital

    Glasgow, Glasgow City G51 4TF
    United Kingdom

    Site Not Available

  • University Hospital of Wales

    Cardiff, CF14 4XW
    United Kingdom

    Site Not Available

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA
    United Kingdom

    Site Not Available

  • Nottingham University Hospital

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Halo Diagnostics

    Indian Wells, California 92210
    United States

    Site Not Available

  • Biogenix Molecular, LLC

    Murrieta, California 92562
    United States

    Site Not Available

  • UC Irvine Medical Center

    Orange, California 92868
    United States

    Site Not Available

  • University of Connecticut Health Center

    Farmington, Connecticut 06030
    United States

    Site Not Available

  • Biogenix Molecular, LLC

    Miami, Florida 33165
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • University of Missouri Hospital and Clinic - Neuroradiology

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Duke University School of Medicine

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Pennsylvania State University College of Medicine

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Wisconsin - Madison

    Madison, Wisconsin 53792
    United States

    Site Not Available

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