A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Known or Suspected Brain or Spinal Cord-related Problems
NCT ID: NCT05915702
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
303 participants
INTERVENTIONAL
2023-07-24
2024-05-31
Brief Summary
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MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a 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 brain and spinal cord-related problems in 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
QUADRUPLE
Study Groups
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Gadoquatrane - Approved Macrocyclic GBCA
Participants will receive one intravenous injection of gadoquatrane before or during MRI in Period 1, followed by one intravenous injection of any approved macrocyclic GBCA before or during MRI in Period 2.
Gadoquatrane (BAY1747846)
0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose
Gadobutrol
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose
Gadoterate meglumine
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose
Gadoteridol
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose
Approved Macrocyclic GBCA - Gadoquatrane
Participants will receive one intravenous injection of any approved macrocyclic GBCA before or during MRI in Period 1, followed by one intravenous injection of gadoquatrane before or during MRI in Period 2.
Gadoquatrane (BAY1747846)
0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose
Gadobutrol
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose
Gadoterate meglumine
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose
Gadoteridol
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose
Interventions
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Gadoquatrane (BAY1747846)
0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose
Gadobutrol
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose
Gadoterate meglumine
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose
Gadoteridol
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with a clinical indication for a contrast-enhanced MRI (including 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, for a known or suspected CNS pathology
* 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
* 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)
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Halo Diagnostics - Indian Wells
Indian Wells, California, United States
University of California Irvine Med. Center / Diagnostic Radiology, Neuroradiology
Orange, California, United States
Biogenix Molecular, LLC
Miami, Florida, United States
Northwestern Memorial Hospital - Radiology
Chicago, Illinois, United States
QUEST Research Institute | Farmington Hills, MI
Farmington Hills, Michigan, United States
MU Health Care - University Hospital - Radiology
Columbia, Missouri, United States
Duke University School of Medicine - Early Phase Research Unit - Neurology
Durham, North Carolina, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Fundacion Cientifica del Sur | Centro de Lomas de Zamora - Imaging Interventionism Department
Lomas de Zamora, Buenos Aires, Buenos Aires, Argentina
Instituto Alexander Fleming | Sede Central - Departamento de Diagnostico por Imagenes
CABA, Ciudad Auton. de Buenos Aires, Argentina
Sanatorio Otamendi | Imaging Diagnostic Center
Ciudad Autonoma de Buenos Aire, Ciudad Auton. de Buenos Aires, Argentina
Centro de Diagnostico Enrique Rossi | Departamento de Investigacion Clínica
Ciudad Autonoma de Buenos Aire, Ciudad Auton. de Buenos Aires, Argentina
Sanatorio Allende | Departamento de Investigación Clínica
Córdoba, , Argentina
Clinica Universitaria Reina Fabiola | Consultorios Externos
Córdoba, , Argentina
Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan
Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Imaging Diagnostic Department
Plovdiv, , Bulgaria
Acibadem City Clinic Multiprofile Hospital for Active Treatm
Sofia, , Bulgaria
University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment Prof. Dr. Alexander Chirkov EAD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Radiology Department
Sofia, , Bulgaria
University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology Department
Sofia, , Bulgaria
MHAT Sveta Marina EAD
Varna, , Bulgaria
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
London Health Sciences Centre (LHSC) - University Hospital
London, , Canada
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University First Hospital - Oncology Department
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital, Captial Medical University
Beijing, Beijing Municipality, China
Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Huai'an First People's Hospital, Nanjing Medical University
Huai'an, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Fakultní nemocnice Brno - Klinika radiologie a nukleární medicíny
Brno, South Moravian, Czechia
Fakultní nemocnice Ostrava
Ostrava - Poruba, , Czechia
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
Pardubice, , Czechia
Fakultni nemocnice Plzen - Lochotin
Pilsen, , Czechia
Všeobecná fakultní nemocnice v Praze
Prague, , Czechia
Fakultní Thomayerova nemocnice - RDG radiodiagnostické oddelení
Prague, , Czechia
Center Hospitalier Michallon - Grenoble
Grenoble, , France
Centre Hospitalier Lyon Sud - Service d'imagerie
Pierre-Bénite, , France
Centre Hospitalo-Universitaire de Strasbourg
Strasbourg, , France
Uniklinik Augsburg / Radiologie
Augsburg, Bavaria, Germany
Universitätsklinikum Essen - Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie - 21181
Essen, North Rhine-Westphalia, Germany
St. Franziskus-Hospital GmbH
Münster, North Rhine-Westphalia, Germany
Uniklinik Kiel /Radiologie und Neuroradiologie
Kiel, Schleswig-Holstein, Germany
Debreceni Egyetem Klinikai Kozpont - Idegsebeszeti Klinika
Debrecen, , Hungary
Szent Damján Görögkatolikus Kórház - Neurologiai es Stroke Osztaly
Kisvárda, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont - Idegsebeszeti Klinika
Pécs, , Hungary
Trial Pharma Kft. Szeged
Szeged, , Hungary
ASL Della Provincia Di Barletta Andria Trani_Ospedale L.Bonomo - Radiodiagnostica
Andria, Apulia, Italy
Azienda Ospedaliero-Universitaria Sant'Andrea - UOC Neuroradiologia
Rome, Lazio, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Radiologia diagnostica per immagini 2 Neuroradiologia
Bergamo, Lombardy, Italy
Kure Kyosai Hospital
Kure, Hiroshima, Japan
Hyogo Prefectural Nishinomiya Hospital
Nishinomiya, Hyōgo, Japan
National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office
Kanazawa, Ishikawa-ken, Japan
Japan Organization of Occupational Health and Safety Kagawa Rosai Hospital
Marugame, Kagawa-ken, Japan
Shonan Fujisawa Tokushukai Hospital
Fujisawa, Kanagawa, Japan
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, Japan
National Hospital Organization Kanmon Medical Center
Shimonoseki, Yamaguchi, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, , Japan
Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital
Fukuoka, , Japan
Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
Osaka, , Japan
Konkuk University Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Karolinska University Hospital, Huddinge Neuroradiology
Stockholm, , Sweden
Karolinska University Hospital, Solna Neuroradiology
Stockholm, , Sweden
Uppsala University Hospital, Neuroradiology Department
Uppsala, , Sweden
Hacettepe Universitesi Tip Fakultesi
Ankara, , Turkey (Türkiye)
Binali Yildirim Universitesi Mengucek Gazi EAH - Radyoloji
Erzincan, , Turkey (Türkiye)
Koc Universitesi Tip Fakultesi - Radyoloji
Istanbul, , Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, , Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
Istanbul, , Turkey (Türkiye)
Ondokuz Mayis Uni Tip Fakultesi
Samsun, , Turkey (Türkiye)
Queen Elizabeth University Hospital
Glasgow, Glasgow City, United Kingdom
Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant
Cardiff, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
Countries
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Related Links
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Other Identifiers
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2022-501884-41-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
21181
Identifier Type: -
Identifier Source: org_study_id
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