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

NCT05915702 | Completed Phase 3 FDA Drug

• 2 other identifiers: 211812022-501884-41-00
• Study Type: interventional
• Target: 303
• Locations: 15 countries
• Sites: 78

Brief Summary

Researchers are looking for a better way to help people with known or suspected 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 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.

Conditions

Contrast Enhancement in Magnetic Resonance Imaging; Central Nervous System Pathology

Outcome Measures

Primary Outcomes (3)

• Visualization parameter contrast Enhancement assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR

  Contrast Enhancement will be assessed on a 4-point scale (1/No: not enhanced, 2/Moderate: weakly enhanced, 3/Good: clearly enhanced, 4/Excellent: clearly and brightly enhanced). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging

  1 day procedure

• Visualization parameter delineation assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR

  Delineation will be assessed on a 4-point scale (1/No: no or unclear delineation, 2/Moderate: some aspects of delineation, 3/Good: almost clear but not complete, 4/Excellent: clear and complete delineation). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging

  1 day procedure

• Visualization parameter morphology assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR

  Morphology will be assessed on a 3-point scale (1/Poor: no or poorly evaluable, 2/Moderate: partially evaluable, 3/Good: sufficiently evaluable). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging

  1 day procedure

Secondary Outcomes (14)

• Visualization parameter contrast assessed by separate blinded evaluation of combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICR

  1 day procedure

• Visualization parameter delineation assessed by separate blinded evaluation of combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICR

  1 day procedure

• Visualization parameter morphology assessed by separate blinded evaluation of combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICR

  1 day procedure

• Sensitivity for the detection of lesions of combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICR

  1 day procedure

• Specificity for the detection of lesions of combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICR

  1 day procedure

Study Arms (2)

Gadoquatrane - Approved Macrocyclic GBCA

EXPERIMENTAL

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.

Drug: Gadoquatrane (BAY1747846); Drug: Gadobutrol; Drug: Gadoterate meglumine; Drug: Gadoteridol

Approved Macrocyclic GBCA - Gadoquatrane

EXPERIMENTAL

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.

Drug: Gadoquatrane (BAY1747846); Drug: Gadobutrol; Drug: Gadoterate meglumine; Drug: Gadoteridol

Interventions

Gadoquatrane (BAY1747846) DRUG

0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose

Approved Macrocyclic GBCA - Gadoquatrane; Gadoquatrane - Approved Macrocyclic GBCA

Gadobutrol DRUG

Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose

Approved Macrocyclic GBCA - Gadoquatrane; Gadoquatrane - Approved Macrocyclic GBCA

Gadoterate meglumine DRUG

Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose

Also known as: Gadoteric acid

Approved Macrocyclic GBCA - Gadoquatrane; Gadoquatrane - Approved Macrocyclic GBCA

Gadoteridol DRUG

Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose

Approved Macrocyclic GBCA - Gadoquatrane; Gadoquatrane - Approved Macrocyclic GBCA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (78)

Halo Diagnostics - Indian Wells

Indian Wells, California, 92210, United States

Location

University of California Irvine Med. Center / Diagnostic Radiology, Neuroradiology

Orange, California, 92868, United States

Location

Biogenix Molecular, LLC

Miami, Florida, 33165, United States

Location

Northwestern Memorial Hospital - Radiology

Chicago, Illinois, 60611, United States

Location

QUEST Research Institute | Farmington Hills, MI

Farmington Hills, Michigan, 48334, United States

Location

MU Health Care - University Hospital - Radiology

Columbia, Missouri, 65212, United States

Location

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

Durham, North Carolina, 27710, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

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

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

Location

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

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

Location

Sanatorio Otamendi | Imaging Diagnostic Center

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

Location

Centro de Diagnostico Enrique Rossi | Departamento de Investigacion Clínica

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

Location

Sanatorio Allende | Departamento de Investigación Clínica

Córdoba, X5000JHQ, Argentina

Location

Clinica Universitaria Reina Fabiola | Consultorios Externos

Córdoba, X5004FHP, Argentina

Location

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

Plovdiv, 4002, Bulgaria

Location

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

Plovdiv, 4002, Bulgaria

Location

Acibadem City Clinic Multiprofile Hospital for Active Treatm

Sofia, 1407, Bulgaria

Location

University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD

Sofia, 1431, Bulgaria

Location

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

Sofia, 1431, Bulgaria

Location

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

Sofia, 1431, Bulgaria

Location

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

Sofia, 1784, Bulgaria

Location

MHAT Sveta Marina EAD

Varna, 9010, Bulgaria

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, QC H4J 1C5, Canada

Location

London Health Sciences Centre (LHSC) - University Hospital

London, N6A 5A5, Canada

Location

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

Peking University First Hospital - Oncology Department

Beijing, Beijing Municipality, 100034, China

Location

Beijing Tiantan Hospital, Captial Medical University

Beijing, Beijing Municipality, 100050, China

Location

Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.

Guangzhou, Guangdong, 510120, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China

Location

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

Huai'an, Jiangsu, 223300, China

Location

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Fakultní nemocnice Brno - Klinika radiologie a nukleární medicíny

Brno, South Moravian, 625 00, Czechia

Location

Fakultní nemocnice Ostrava

Ostrava - Poruba, 708 52, Czechia

Location

Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice

Pardubice, 530 03, Czechia

Location

Fakultni nemocnice Plzen - Lochotin

Pilsen, 32300, Czechia

Location

Všeobecná fakultní nemocnice v Praze

Prague, 12808, Czechia

Location

Fakultní Thomayerova nemocnice - RDG radiodiagnostické oddelení

Prague, 14059, Czechia

Location

Center Hospitalier Michallon - Grenoble

Grenoble, 38043, France

Location

Centre Hospitalier Lyon Sud - Service d'imagerie

Pierre-Bénite, 69310, France

Location

Centre Hospitalo-Universitaire de Strasbourg

Strasbourg, 67200, France

Location

Uniklinik Augsburg / Radiologie

Augsburg, Bavaria, 86156, Germany

Location

Universitätsklinikum Essen - Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie - 21181

Essen, North Rhine-Westphalia, 45147, Germany

Location

St. Franziskus-Hospital GmbH

Münster, North Rhine-Westphalia, 48145, Germany

Location

Uniklinik Kiel /Radiologie und Neuroradiologie

Kiel, Schleswig-Holstein, 24105, Germany

Location

Debreceni Egyetem Klinikai Kozpont - Idegsebeszeti Klinika

Debrecen, 4032, Hungary

Location

Szent Damján Görögkatolikus Kórház - Neurologiai es Stroke Osztaly

Kisvárda, 4600, Hungary

Location

Pecsi Tudomanyegyetem Klinikai Kozpont - Idegsebeszeti Klinika

Pécs, 7623, Hungary

Location

Trial Pharma Kft. Szeged

Szeged, 6726, Hungary

Location

ASL Della Provincia Di Barletta Andria Trani_Ospedale L.Bonomo - Radiodiagnostica

Andria, Apulia, 76123, Italy

Location

Azienda Ospedaliero-Universitaria Sant'Andrea - UOC Neuroradiologia

Rome, Lazio, 00189, Italy

Location

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Radiologia diagnostica per immagini 2 Neuroradiologia

Bergamo, Lombardy, 24127, Italy

Location

Kure Kyosai Hospital

Kure, Hiroshima, 737-8505, Japan

Location

Hyogo Prefectural Nishinomiya Hospital

Nishinomiya, Hyōgo, 662-0918, Japan

Location

National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office

Kanazawa, Ishikawa-ken, 920-8650, Japan

Location

Japan Organization of Occupational Health and Safety Kagawa Rosai Hospital

Marugame, Kagawa-ken, 763-8502, Japan

Location

Shonan Fujisawa Tokushukai Hospital

Fujisawa, Kanagawa, 251-0041, Japan

Location

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, 596-0042, Japan

Location

National Hospital Organization Kanmon Medical Center

Shimonoseki, Yamaguchi, 752-8510, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, 810-8563, Japan

Location

Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital

Fukuoka, 811-0213, Japan

Location

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

Osaka, 534-0021, Japan

Location

Konkuk University Medical Center

Seoul, Seoul Teugbyeolsi, 05030, South Korea

Location

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 3080, South Korea

Location

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

Karolinska University Hospital, Huddinge Neuroradiology

Stockholm, 141 86, Sweden

Location

Karolinska University Hospital, Solna Neuroradiology

Stockholm, 17177, Sweden

Location

Uppsala University Hospital, Neuroradiology Department

Uppsala, 75185, Sweden

Location

Hacettepe Universitesi Tip Fakultesi

Ankara, 6100, Turkey (Türkiye)

Location

Binali Yildirim Universitesi Mengucek Gazi EAH - Radyoloji

Erzincan, 24100, Turkey (Türkiye)

Location

Koc Universitesi Tip Fakultesi - Radyoloji

Istanbul, 34010, Turkey (Türkiye)

Location

Istanbul Universitesi Istanbul Tip Fakultesi

Istanbul, 34093, Turkey (Türkiye)

Location

Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

Istanbul, 34098, Turkey (Türkiye)

Location

Ondokuz Mayis Uni Tip Fakultesi

Samsun, 55139, Turkey (Türkiye)

Location

Queen Elizabeth University Hospital

Glasgow, Glasgow City, G51 4TF, United Kingdom

Location

Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant

Cardiff, CF14 4XW, United Kingdom

Location

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Related Links

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MeSH Terms

Interventions

gadobutrol; gadoterate meglumine; gadoteridol

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The site staff in charge of the preparation and administration of study intervention will be unblinded and will not be involved in any evaluation of safety and efficacy. The site staff in charge of conducting all other study procedures as per the schedule of activities (SoA) will remain blinded to the study intervention administered.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: July 24, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 31, 2024
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); AR (6); DE (4); CN (9); GB (3); BU (8); FR (3); HU (4); JP (10); KR (3); IT (3); TU (6); SE (3); CA (2); CZ (6)