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)

PHASE3CompletedINTERVENTIONAL
Enrollment

404

Participants

Timeline

Start Date

July 24, 2023

Primary Completion Date

May 31, 2024

Study Completion Date

June 1, 2024

Conditions
Contrast Enhancement in Magnetic Resonance ImagingNon-central 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 (85)

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 - Onkologiai Klinika, Debrecen

6726

Trial Pharma Kft. Szeged, Szeged

7625

Pecsi Tudomanyegyetem Klinikai Kozpont, Pécs

12808

Všeobecná fakultní nemocnice v Praze, Prague

13125

Helios Klinikum Berlin-Buch - Klinik für Kardiologie - Kardio MRT, Berlin

14186

Karolinska University Hospital Huddinge Radiology, Stockholm

16499

Ajou University Hospital, Suwon

17033

Pennsylvania State University College of Medicine, Hershey

21079

Centre Hospitalier Universitaire de Dijon, Dijon

24100

Binali Yildirim Universitesi Mengucek Gazi EAH - Radyoloji, Erzincan

25123

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - Radiologia Diagnostica 1, Brescia

27710

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

31100

AULSS N. 2 Marca Trevigiana_Ospedale di Treviso - UOC Radiologia, Treviso

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

35233

University of Alabama at Birmingham, Birmingham

37075

Universitätsmedizin Göttingen - Institut für Diagnostische und Interventionelle Radiologie, Göttingen

45147

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

49933

Centre Hospitalier Universitaire - Angers, Angers

53127

Uniklinik Bonn / Radiologie, Bonn

55139

Ondokuz Mayis Uni Tip Fakultesi, Samsun

65212

University of Missouri Hospital and Clinic - Neuroradiology, Columbia

69500

Hospices Civils de LYON, Bron

75018

Hôpital Bichat Claude Bernard - Service de radiologie, Paris

77030

Houston Methodist Hospital - Cardiology, Houston

79106

Uniklinik Freiburg / Radiologie, Freiburg im Breisgau

92210

Halo Diagnostics - Indian Wells, Indian Wells

92868

UC Irvine Medical Center, Orange

100020

Beijing Chaoyang Hospital, Capital Medical University, Beijing

100034

Peking University First Hospital, Beijing

100730

Beijing Hospital, 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

510515

Nanfang Hospital, Southern Medical University, Guangzhou

510630

The First Affiliated Hospital of Jinan University, Guangzhou

610041

West China Hospital Sichuan University, Chengdu

06032

University of Connecticut Health Center, Farmington

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"

"University Multiprofile Hospital for Active Treatment Dr Georgi Stranski Pleven , Surgery Department"

"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"

"Acibadem City Clinic , University Multiprofile Hospital for Active Treatment Tokuda - Radiology Department"

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

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

QC H4J 1C5

Hopital du Sacre-Coeur de Montreal, Montreal

625 00

Fakultní nemocnice Brno - Klinika radiologie a nukleární medicíny, Brno

708 00

Fakultní nemocnice Ostrava - Radiodiagnostický ústav, Ostrava

530 03

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

140 00

Fakultní Thomayerova nemocnice - klinicko-farmakologická jednotka, Praha 4 - Krc

04289

Helios Herzzentrum Leipzig - Abteilung für Radiologie, Leipzig

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

00189

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

806-8501

JCHO Kyushu Hospital, Kitakyushu

807-8556

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

040-8585

Hakodate Central General Hospital, Hakodate

060-8648

Hokkaido University Hospital, Sapporo

662-0918

Hyogo Prefectural Nishinomiya Hospital, Nishinomiya

Ishikawa-ken

"Public Central Hospital of Matto Ishikawa , Clinical Trial Management Office"

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

760-0017

Takamatsu Red Cross Hospital, Takamatsu

596-0042

Kishiwada Tokushukai Hospital, Kishiwada

683-8605

Japan Organization of Occupational Health and Safety Sanin Rosai Hospital, Yonago

752-8510

National Hospital Organization Kanmon Medical Center, Shimonoseki

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

15-402

NZOZ Kendron, Bialystok

80-214

Uniwersyteckie Centrum Kliniczne, Gdansk

91-053

Centra Medyczne Medyceusz, Lodz

01-785

Centrum Medycznym Gamma, Warsaw

751 85

Akademiska Sjukhuset, Uppsala

G51 4TF

Queen Elizabeth University Hospital, Glasgow

CF14 4XW

University Hospital of Wales, Cardiff

NG7 2UH

Nottingham University Hospital, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT05915728 - 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) | Biotech Hunter | Biotech Hunter