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

PHASE3CompletedINTERVENTIONAL
Enrollment

303

Participants

Timeline

Start Date

July 24, 2023

Primary Completion Date

May 30, 2024

Study Completion Date

May 31, 2024

Conditions
Contrast Enhancement in Magnetic Resonance ImagingCentral Nervous System Pathology
Interventions
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

DRUG

Gadoteridol

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

Trial Locations (78)

1407

Acibadem City Clinic Multiprofile Hospital for Active Treatm, Sofia

1431

University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD, Sofia

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

3080

Seoul National University Hospital, Seoul

4032

Debreceni Egyetem Klinikai Kozpont - Idegsebeszeti Klinika, Debrecen

4600

Szent Damján Görögkatolikus Kórház - Neurologiai es Stroke Osztaly, Kisvárda

6100

Hacettepe Universitesi Tip Fakultesi, Ankara

6726

Trial Pharma Kft. Szeged, Szeged

7623

Pecsi Tudomanyegyetem Klinikai Kozpont - Idegsebeszeti Klinika, Pécs

9010

MHAT Sveta Marina EAD, Varna

12808

Všeobecná fakultní nemocnice v Praze, Prague

14059

Fakultní Thomayerova nemocnice - RDG radiodiagnostické oddelení, Prague

17033

Penn State Milton S. Hershey Medical Center, Hershey

17177

Karolinska University Hospital, Solna Neuroradiology, Stockholm

24100

Binali Yildirim Universitesi Mengucek Gazi EAH - Radyoloji, Erzincan

24105

Uniklinik Kiel /Radiologie und Neuroradiologie, Kiel

24127

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

27710

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

32300

Fakultni nemocnice Plzen - Lochotin, Pilsen

33165

Biogenix Molecular, LLC, Miami

34010

Koc Universitesi Tip Fakultesi - Radyoloji, Istanbul

34093

Istanbul Universitesi Istanbul Tip Fakultesi, Istanbul

34098

Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi, Istanbul

38043

Center Hospitalier Michallon - Grenoble, Grenoble

45147

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

47392

Inje University Busan Paik Hospital, Busan

48145

St. Franziskus-Hospital GmbH, Münster

55139

Ondokuz Mayis Uni Tip Fakultesi, Samsun

60611

Northwestern Memorial Hospital - Radiology, Chicago

65212

MU Health Care - University Hospital - Radiology, Columbia

67200

Centre Hospitalo-Universitaire de Strasbourg, Strasbourg

69310

Centre Hospitalier Lyon Sud - Service d'imagerie, Pierre-Bénite

75185

Uppsala University Hospital, Neuroradiology Department, Uppsala

76123

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

86156

Uniklinik Augsburg / Radiologie, Augsburg

92210

Halo Diagnostics - Indian Wells, Indian Wells

92868

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

100020

Beijing Chaoyang Hospital, Capital Medical University, Beijing

100034

Peking University First Hospital - Oncology Department, Beijing

100050

Beijing Tiantan Hospital, Captial Medical University, Beijing

210009

Zhongda Hospital Southeast University, Nanjing

223300

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

325000

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

510120

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

510515

Nanfang Hospital, Southern Medical University, Guangzhou

510630

The First Affiliated Hospital of Jinan University, Guangzhou

Michigan

"QUEST Research Institute , Farmington Hills, MI"

Buenos Aires

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

Ciudad Auton. de Buenos Aires

"Instituto Alexander Fleming , Sede Central - Departamento de Diagnostico por Imagenes"

"Sanatorio Otamendi , Imaging Diagnostic Center"

"Centro de Diagnostico Enrique Rossi , Departamento de Investigacion Clínica"

Unknown

"Sanatorio Allende , Departamento de Investigación Clínica"

"Clinica Universitaria Reina Fabiola , Consultorios Externos"

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

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

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

"University Hospital for Active Treatment Tsaritsa Joanna - ISUL , Radiology Department"

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

QC H4J 1C5

Hopital du Sacre-Coeur de Montreal, Montreal

N6A 5A5

London Health Sciences Centre (LHSC) - University Hospital, London

625 00

Fakultní nemocnice Brno - Klinika radiologie a nukleární medicíny, Brno

708 52

Fakultní nemocnice Ostrava, Ostrava - Poruba

530 03

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

00189

Azienda Ospedaliero-Universitaria Sant'Andrea - UOC Neuroradiologia, Rome

737-8505

Kure Kyosai Hospital, Kure

662-0918

Hyogo Prefectural Nishinomiya Hospital, Nishinomiya

Ishikawa-ken

"National Hospital Organization Kanazawa Medical Center , Clinical Trial Management Office"

763-8502

Japan Organization of Occupational Health and Safety Kagawa Rosai Hospital, Marugame

251-0041

Shonan Fujisawa Tokushukai Hospital, Fujisawa

596-0042

Kishiwada Tokushukai Hospital, Kishiwada

752-8510

National Hospital Organization Kanmon Medical Center, Shimonoseki

810-8563

National Hospital Organization Kyushu Medical Center, Fukuoka

811-0213

Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital, Fukuoka

534-0021

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

05030

Konkuk University Medical Center, Seoul

141 86

Karolinska University Hospital, Huddinge Neuroradiology, Stockholm

G51 4TF

Queen Elizabeth University Hospital, Glasgow

W6 8RF

Charing Cross Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT05915702 - 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 | Biotech Hunter | Biotech Hunter