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 (Quanti CNS)

• ClinicalTrials.gov Identifier: NCT05915702
• Recruitment Status: Recruiting
• First Posted: June 23, 2023
• Last Update Posted: May 8, 2024
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Contrast Enhancement in Magnetic Resonance Imaging; Central Nervous System Pathology	Drug: Gadoquatrane (BAY1747846); Drug: Gadobutrol; Drug: Gadoterate meglumine; Drug: Gadoteridol	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 295 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Diagnostic
• Official Title: A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of the Central Nervous System (CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)
• Actual Study Start Date: July 24, 2023
• Estimated Primary Completion Date: July 15, 2024
• Estimated Study Completion Date: July 16, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Gadoquatrane (BAY1747846); 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose; Drug: Gadobutrol; Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose; Drug: Gadoterate meglumine; Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose; Other Name: Gadoteric acid; Drug: Gadoteridol; Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose
Experimental: 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.	Drug: Gadoquatrane (BAY1747846); 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose; Drug: Gadobutrol; Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose; Drug: Gadoterate meglumine; Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose; Other Name: Gadoteric acid; Drug: Gadoteridol; Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose

Outcome Measures

Primary Outcome Measures :

1. Visualization parameter contrast Enhancement assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR [ Time Frame: 1 day procedure ]
   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
2. Visualization parameter delineation assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR [ Time Frame: 1 day procedure ]
   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
3. Visualization parameter morphology assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR [ Time Frame: 1 day procedure ]
   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

Secondary Outcome Measures :

1. 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 [ Time Frame: 1 day procedure ]
   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; GBCAs = gadolinium-based contrast agents
2. 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 [ Time Frame: 1 day procedure ]
   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; GBCAs = gadolinium-based contrast agents
3. 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 [ Time Frame: 1 day procedure ]
   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; GBCAs = gadolinium-based contrast agents
4. 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 [ Time Frame: 1 day procedure ]
   BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
5. 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 [ Time Frame: 1 day procedure ]
   BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
6. The overall diagnostic clinical value of combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs [ Time Frame: 1 day procedure ]
   The overall diagnostic clinical value is composed of 2 elements and based on: i.the evaluation of diagnostic descriptive imaging features adapted from radiologic reporting standards (detection/exclusion of enhancing pathology; location, extent, and pattern of enhancement) on a 5-point scale (1- no diagnostic clinical value from contrast enhancement, 2- poor diagnostic clinical value from contrast enhancement, 3- moderate diagnostic clinical value from contrast enhancement, 4- good diagnostic clinical value from contrast enhancement, 5- excellent diagnostic clinical value from contrast enhancement), by the BICR and the Investigator; ii. the evaluation of patient management based on the diagnostic reporting recommendations (i.e., likely diagnosis), by the Investigator. BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging
7. Sensitivity for the detection of malignant lesions of combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs assessed by BICR and the investigator [ Time Frame: 1 day procedure ]
   BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
8. Specificity for the detection of malignant lesions of combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs assessed by BICR and the investigator [ Time Frame: 1 day procedure ]
   BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
9. Diagnoses from combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs by the Investigator [ Time Frame: 1 day procedure ]
   BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
10. Confidence in diagnosis combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs by BICR and by Investigator on 4PS [ Time Frame: 1 day procedure ]
    The degree of confidence will be rated on a 4-point scale: 1 = Not confident， 2 = Somewhat confident, 3 = Confident, 4 = Very confident. BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
11. Number of lesions seen on unenhanced MRI image set and combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICR [ Time Frame: 1 day procedure ]
    BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
12. Number of enhancing lesions seen on combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICR [ Time Frame: 1 day procedure ]
    BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
13. Number of participants with treatment emergent adverse events, including number of serious adverse events, after administration of gadoquatrane compared to macrocyclic GBCAs reported by the investigator [ Time Frame: Within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic GBCAs ]
    GBCAs = gadolinium-based contrast agents
14. Number of participants with treatment emergent adverse events, including number of serious adverse events, per intensity after administration of gadoquatrane compared to macrocyclic GBCAs reported by the investigator [ Time Frame: Within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic GBCAs ]
    GBCAs = gadolinium-based contrast agents

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 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:

• 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)

Contacts and Locations

Contacts

Contact: Bayer Clinical Trials Contact; (+)1-888-84 22937; clinical-trials-contact@bayer.com

Locations

United States, California

Halo Diagnostics; Recruiting

Indian Wells, California, United States, 92210

University of California Irvine Med. Center / Diagnostic Radiology, Neuroradiology; Not yet recruiting

Orange, California, United States, 92868

United States, Connecticut

University of Connecticut Health Center; Not yet recruiting

Farmington, Connecticut, United States, 06032

United States, Florida

Biogenix Molecular, LLC; Not yet recruiting

Miami, Florida, United States, 33165

United States, Illinois

Northwestern University - Dept. of Radiology; Not yet recruiting

Chicago, Illinois, United States, 60611

United States, Michigan

Quest Research Institute Neuroradiology; Recruiting

Farmington Hills, Michigan, United States, 48334

United States, Minnesota

Mayo Clinic - Rochester; Withdrawn

Rochester, Minnesota, United States, 55905

United States, Missouri

University of Missouri -Radiology - Columbia; Recruiting

Columbia, Missouri, United States, 65212

United States, North Carolina

Duke University School of Medicine; Not yet recruiting

Durham, North Carolina, United States, 27710

United States, Pennsylvania

Penn State Milton S. Hershey Medical Center; Not yet recruiting

Hershey, Pennsylvania, United States, 17033

United States, South Carolina

Medical University of South Carolina - Radiology; Withdrawn

Charleston, South Carolina, United States, 29425

United States, Texas

University of Texas Southwestern Medical Center; Withdrawn

Dallas, Texas, United States, 75235-3858

Argentina

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

Lomas De Zamora, Buenos Aires, Buenos Aires, Argentina, B1832BRQ

Sanatorio Otamendi | Imaging Diagnostic Center; Recruiting

Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1115AAB

Centro de Diagnóstico Dr. Enrique Rossi; Recruiting

Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1425BEE

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

Caba, Ciudad Auton. De Buenos Aires, Argentina, C1426

Sanatorio Allende | Departamento de Investigación Clínica; Recruiting

Córdoba, Argentina, X5000JHQ

Clinica Universitaria Reina Fabiola | Consultorios Externos; Recruiting

Córdoba, Argentina, X5004FHP

Bulgaria

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

Plovdiv, Bulgaria, 4002

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

Plovdiv, Bulgaria, 4002

Acibadem City Clinic Multiprofile Hospital for Active Treatm; Withdrawn

Sofia, Bulgaria, 1407

UMHAT Alexandrovska EAD; Recruiting

Sofia, Bulgaria, 1431

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

Sofia, Bulgaria, 1431

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

Sofia, Bulgaria, 1431

UMHAT Tsaritsa Joanna-ISUL EAD Sofia; Recruiting

Sofia, Bulgaria, 1606

MHAT Sveta Marina EAD; Recruiting

Varna, Bulgaria, 9010

Canada, Ontario

St.Joseph's Health Care-London; Not yet recruiting

London, Ontario, Canada, N6G 2M3

Princess Margaret Hospital-University Health Network; Withdrawn

Toronto, Ontario, Canada, M5G 2M9

Canada, Quebec

Hopital du Sacre-Coeur de Montreal; Recruiting

Montreal, Quebec, Canada, QC H4J 1C5

Canada

London Health Sciences Centre (LHSC) - University Hospital; Not yet recruiting

London, Canada, N6A 5A5

China, Guangdong

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

Guangzhou, Guangdong, China, 510120

Nanfang Hospital, Southern Medical University; Recruiting

Guangzhou, Guangdong, China, 510515

The First Affiliated Hospital of Jinan University; Recruiting

Guangzhou, Guangdong, China, 510630

China, Jiangsu

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

Huai'An, Jiangsu, China, 223300

Zhongda Hospital Southeast University; Recruiting

Nanjing, Jiangsu, China, 210009

China, Zhejiang

The First Affiliated Hospital of Wenzhou Medical University; Recruiting

Wenzhou, Zhejiang, China, 325000

China

Beijing Chaoyang Hospital, Capital Medical University; Recruiting

Beijing, China, 100020

Peking University First Hospital; Recruiting

Beijing, China, 100034

Beijing Tiantan Hospital, Captial Medical University; Recruiting

Beijing, China, 100050

Czechia

Fakultni nemocnice Brno; Recruiting

Brno, Czechia, 625 00

Fakultni nemocnice Ostrava; Recruiting

Ostrava, Czechia, 708 52

Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice; Not yet recruiting

Pardubice, Czechia, 530 03

Fakultni nemocnice Plzen - Lochotin; Recruiting

Plzen-Lochotin, Czechia, 323 00

Fakultni Thomayerova Nemocnice; Recruiting

Prague, Czechia, 140 59

Vseobecna fakultni nemocnice v Praze; Recruiting

Praha 2, Czechia, 12808

France

Center Hospitalier Michallon - Grenoble; Recruiting

La Tronche, France, 38700

Centre Hospitalier Lyon Sud; Recruiting

Pierre Benite, France, 69495

CHU STRASBOURG - Hôpital de Hautepierre; Recruiting

Strasbourg Cedex, France, 67098

Germany

Uniklinik Augsburg / Radiologie; Recruiting

Augsburg, Bayern, Germany, 86156

Universitätsklinikum Essen; Recruiting

Essen, Nordrhein-Westfalen, Germany, 45122

St. Franziskus-Hospital GmbH; Recruiting

Münster, Nordrhein-Westfalen, Germany, 48145

Uniklinik Kiel /Radiologie und Neuroradiologie; Recruiting

Kiel, Schleswig-Holstein, Germany, 24105

Hungary

Semmelweis Egyetem Idegsebeszeti es Neurointervencios Klinika; Not yet recruiting

Budapest, Hungary, 1145

Debreceni Egyetem Klinikai Kozpont, Idegsebeszeti Klinika; Recruiting

Debrecen, Hungary, 4032

Kistarcsai Flor Ferenc Korhaz; Withdrawn

Kistarcsa, Hungary, 2143

Szent Damjan Gorogkatolikus Korhaz; Recruiting

Kisvarda, Hungary, 4600

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

Miskolc, Hungary, 3526

Idegsebeszeti Klinika; Recruiting

Pecs, Hungary, 7623

Trial Pharma Kft. Szeged; Recruiting

Szeged, Hungary, 6726

Italy

A.O.U. Sant'Andrea; Recruiting

Roma, Lazio, Italy, 00189

ASST Papa Giovanni XXIII; Recruiting

Bergamo, Lombardia, Italy, 24127

Ospedale San Raffaele s.r.l.; Not yet recruiting

Milano, Lombardia, Italy, 20132

ASL Provincia di Barletta-Andria-Trani; Recruiting

Andria, Puglia, Italy, 70031

Japan

Hospital of the University of Occupational and Environmental Health, Japan; Not yet recruiting

Kitakyushu, Fukuoka, Japan, 807-8556

Kure Kyosai Hospital; Recruiting

Kure, Hiroshima, Japan, 737-8505

Hokkaido University Hospital; Not yet recruiting

Sapporo, Hokkaido, Japan, 060-8648

Hyogo Prefectural Nishinomiya Hospital; Recruiting

Nishinomiya, Hyogo, Japan, 662-0918

National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office; Recruiting

Kanazawa, Ishikawa, Japan, 920-8650

Japan Organization of Occupational Health and Safety Kagawa Rosai Hospital; Recruiting

Marugame, Kagawa, Japan, 763-8502

Shonan Fujisawa Tokushukai Hospital; Recruiting

Fujisawa, Kanagawa, Japan, 251-0041

Kishiwada Tokushukai Hospital; Recruiting

Kishiwada, Osaka, Japan, 596-0042

National Hospital Organization Kanmon Medical Center; Recruiting

Shimonoseki, Yamaguchi, Japan, 752-8510

National Hospital Organization Kyushu Medical Center; Recruiting

Fukuoka, Japan, 810-8563

Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital; Recruiting

Fukuoka, Japan, 811-0213

Osaka City General Hospital; Recruiting

Osaka, Japan, 534-0021

Korea, Republic of

Ajou University Hospital; Not yet recruiting

Suwon, Gyeonggido, Korea, Republic of, 443-721

Asan Medical Center; Not yet recruiting

Seoul, Seoul Teugbyeolsi, Korea, Republic of, 138-736

Seoul National University Hospital; Recruiting

Seoul, Seoul Teugbyeolsi, Korea, Republic of, 3080

Konkuk University Medical Center; Recruiting

Seoul, Seoul Teugbyeolsi, Korea, Republic of, 5030

Inje University Busan Paik Hospital; Recruiting

Busan, Korea, Republic of, 47392

Sweden

Karolinska University Hospital, Huddinge Neuroradiology; Recruiting

Stockholm, Sweden, 141 86

Karolinska University Hospital, Solna Neuroradiology; Recruiting

Stockholm, Sweden, 17177

Uppsala University Hospital, Neuroradiology Department; Recruiting

Uppsala, Sweden, 75185

Turkey

Lokman Hekim Universitesi Tip Fakultesi - Radyoloji; Not yet recruiting

Ankara, Turkey, 06510

Hacettepe Universitesi Tip Fakultesi; Not yet recruiting

Ankara, Turkey, 06532

Binali Yildirim Universitesi Mengucek Gazi EAH - Radyoloji; Recruiting

Erzincan, Turkey, 24610

Koc Universitesi Tip Fakultesi - Radyoloji; Recruiting

Istanbul, Turkey, 34010

Istanbul Universitesi Istanbul Tip Fakultesi; Recruiting

Istanbul, Turkey, 34093

Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi; Recruiting

Istanbul, Turkey, 34098

Ondokuz Mayis Uni Tip Fakultesi; Not yet recruiting

Samsun, Turkey, 55139

United Kingdom

Queen Elizabeth University Hospital; Recruiting

Glasgow, Glasgow City, United Kingdom, G51 4TF

University Hospital of Wales; Not yet recruiting

Cardiff, United Kingdom, CF14 4XW

Royal Infirmary of Edinburgh; Withdrawn

Edinburgh, United Kingdom, EH16 4SA

Charing Cross Hospital; Recruiting

London, United Kingdom, W6 8RF

Sponsors and Collaborators

Bayer

More Information

Additional Information:

Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field. 

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT05915702
• Other Study ID Numbers: 21181; 2022-501884-41-00 ( Registry Identifier: CTIS (EU) )
• First Posted: June 23, 2023
• Last Update Posted: May 8, 2024
• Last Verified: May 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate; Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action