Phase
Condition
N/ATreatment
Gadoteridol
Gadoterate meglumine
Gadoquatrane (BAY1747846)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be >= 18 years of age inclusive, at the time of signing theinformed consent form
Participants with a clinical indication for a contrast-enhanced MRI (includingmagnetic resonance angiography [MRA]), with any approved standard of caremacrocyclic GBCA with proven efficacy, safety and tolerability in clinical routineCE-MRI/MRA (gadobutrol, gadoterate meglumine/ gadoteric acid or gadoteridol) that isused at the site for the indication, with known or suspected pathology of any bodyregion, e.g. head and neck (except central nervous system [CNS]), thorax (includinge.g. breast, heart, chest wall), abdomen (including e.g. liver, kidney, pancreas),pelvis (including e.g. prostate, uterus, ovaries), extremities (including upper andlower.
Participants who can undergo study-related procedures, including 2 contrast-enhancedMRI 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 regulationsregarding the methods of contraception for those participating in clinical studies.A female participant is eligible to participate if she is not pregnant orbreastfeeding, and one of the following conditions applies: Is a woman ofnonchildbearing 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
Exclusion Criteria:
Considered clinically unstable or has a concurrent/concomitant condition that maysignificantly alter image comparability between the 2 study MRIs or between studyparameters (e.g. safety, pharmacokinetics [PK] parameters) or would not allowparticipation for the full planned study period, in the judgement of theinvestigator
Participants presenting with severe renal insufficiency, defined as an estimatedglomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2, derived from a serum orplasma creatinine sample obtained within 48 hours prior to the first contrast agentinjection in the study
Participants with acute kidney injury (i.e., acute renal failure), regardless ofeGFR
History of moderate to severe allergic-like reaction to any GBCA
Bronchial asthma considered unstable or who have had recent modification to theirmedical therapy
Receipt of any contrast agent < 72 h prior to the study MRIs or planned to receiveany 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. biopsyor surgery in the region of interest) or change in treatment (e.g. start ofchemotherapy or antiangiogenic therapy, significant change in corticosteroids dose)that may significantly alter image comparability between the 2 MRIs or other studyparameters (i.e. safety/adverse events [AEs] [e.g. confounding AEs or safety eventsdue to surgery or chemotherapy], PK parameters), from the first study MRI up to 24 hafter the second study MRI
Has received any investigational product within 30 days, or within 5 times half-lifeof the investigational product, whatever is shorter, prior to or concurrent withthis study
Contraindications to the administration of macrocyclic GBCAs (depending on localproduct label), or history of adverse reaction to gadoquatrane
Any contraindication to MRI examinations based on institution policy andinvestigator's clinical judgement (e.g. some metallic implants or active implants)
Study Design
Connect with a study center
Fundacion Cientifica del Sur
Lomas De Zamora, Buenos Aires, Buenos Aires B1832BRQ
ArgentinaSite Not Available
Fundacion Cientifica del Sur | Centro de Lomas de Zamora - Imaging Interventionism Department
Lomas De Zamora, Buenos Aires, Buenos Aires B1832BRQ
ArgentinaSite Not Available
Fundacion Cientifica del Sur
Lornas De Zamora, Buenos Aires B1832BQS
ArgentinaSite Not Available
Centro de Diagnóstico Dr. Enrique Rossi
Buenos Aires, Ciudad Auton. De Buenos Aires C1425BEE
ArgentinaSite Not Available
Sanatorio Otamendi
Buenos Aires, Ciudad Auton. De Buenos Aires C1115AAB
ArgentinaActive - Recruiting
Sanatorio Otamendi | Imaging Diagnostic Center
Buenos Aires, Ciudad Auton. De Buenos Aires C1115AAB
ArgentinaSite Not Available
Instituto Alexander Fleming | Sede Central - Departamento de Diagnostico por Imagenes
Caba, Ciudad Auton. De Buenos Aires C1426
ArgentinaSite Not Available
Instituto Medico Especializado Alexander Fleming
Caba, Ciudad Auton. De Buenos Aires C1426
ArgentinaSite Not Available
Clinica Universitaria Reina Fabiola | Consultorios Externos
Cordoba, Córdoba X5004FHP
ArgentinaSite Not Available
Clinica Universitaria Reina Fabiola | Consultorios Externos
Córdoba, X5004FHP
ArgentinaActive - Recruiting
Clínica Universitaria Reina Fabiola
Córdoba, X5004FHP
ArgentinaSite Not Available
Sanatorio Allende | Departamento de Investigación Clínica
Córdoba, X5000JHQ
ArgentinaSite Not Available
UMHAT Dr. Georgi Stranski
Pleven, 5800
BulgariaSite Not Available
University Multiprofile Hospital for Active Treatment Dr Georgi Stranski Pleven | Surgery Department
Pleven, 5800
BulgariaSite Not Available
MHAT Central Onco Hospital
Plovdiv, 4002
BulgariaSite Not Available
Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan
Plovdiv, 4002
BulgariaSite Not Available
UMHAT Sveti Georgi
Plovdiv, 4000
BulgariaSite Not Available
University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Imaging Diagnostic Department
Plovdiv, 4002
BulgariaSite Not Available
Acibadem City Clinic Multiprofile Hospital for Active Treatm
Sofia, 1407
BulgariaSite Not Available
Acibadem City Clinic | University Multiprofile Hospital for Active Treatment Tokuda - Radiology Department
Sofia, 1407
BulgariaSite Not Available
UMHAT Alexandrovska EAD
Sofia, 1431
BulgariaSite Not Available
UMHAT Prof. Dr Aleksandar Chirkov
Sofia, 1431
BulgariaActive - Recruiting
UMHAT Tsaritsa Yoanna-ISUL Clinic of imaging diagnostic
Sofia, 1527
BulgariaSite Not Available
University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology Department
Sofia, 1784
BulgariaSite Not Available
University Multiprofile Hosp. for Active Treat. Sveti Ivan
Sofia, 1431
BulgariaSite Not Available
University Multiprofile Hospital for Active Treatment Prof. Dr. Alexander Chirkov EAD
Sofia, 1431
BulgariaSite Not Available
St.Joseph's Health Care-London
London, Ontario N6G 2M3
CanadaSite Not Available
Princess Margaret Hospital-University Health Network
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Toronto General Hospital UHN
Toronto, Ontario M5G 2C4
CanadaSite Not Available
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec QC H4J 1C5
CanadaSite Not Available
London Health Sciences Centre (LHSC) - University Hospital
London, N6A 5A5
CanadaSite Not Available
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong 510515
ChinaSite Not Available
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong 510630
ChinaSite Not Available
Huai'an First People's Hospital, Nanjing Medical University
Huai'An, Jiangsu 223300
ChinaSite Not Available
Zhongda Hospital Southeast University
Nanjing, Jiangsu 210009
ChinaSite Not Available
West China Hospital Sichuan University
Chengdu, Sichuan 610041
ChinaSite Not Available
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang 325000
ChinaSite Not Available
Beijing Chaoyang Hospital, Capital Medical University
Beijing, 100020
ChinaSite Not Available
Beijing Hospital
Beijing, 100730
ChinaSite Not Available
Peking University First Hospital
Beijing, 100034
ChinaSite Not Available
Fakultni nemocnice Brno
Brno, 625 00
CzechiaSite Not Available
Fakultni nemocnice Ostrava
Ostrava, 708 52
CzechiaSite Not Available
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
Pardubice, 530 03
CzechiaSite Not Available
Fakultni nemocnice Plzen - Lochotin
Plzen, 32300
CzechiaSite Not Available
Fakultni nemocnice Plzen - Lochotin
Plzen-Lochotin, 323 00
CzechiaSite Not Available
Fakultni Thomayerova Nemocnice
Prague, 140 59
CzechiaSite Not Available
Vseobecna fakultni nemocnice v Praze
Praha 2, 12808
CzechiaSite Not Available
Fakultni Thomayerova Nemocnice
Praha 4, 140 59
CzechiaSite Not Available
Centre Hospitalier Universitaire - Angers
Angers, 49933
FranceSite Not Available
Centre Hospitalier Universitaire de Dijon
Dijon, 21079
FranceSite Not Available
Hôpital Général - Dijon
Dijon, 21033
FranceSite Not Available
Hospices Civils de LYON
Lyon, 69229
FranceSite Not Available
Hopital Bichat - Paris
Paris, 75018
FranceSite Not Available
Uniklinik Freiburg / Radiologie
Freiburg, Baden-Württemberg 79106
GermanySite Not Available
Universitätsmed Göttingen Institut f. Diag&Interv Radiologie
Göttingen, Niedersachsen 37075
GermanySite Not Available
Uniklinik Bonn / Radiologie
Bonn, Nordrhein-Westfalen 53127
GermanySite Not Available
Helios Herzzentrum Leipzig - Abteilung für Radiologie
Leipzig, Sachsen 04289
GermanySite Not Available
Universitätsklinikum Aachen / Klinik für Diagnostische und Interventionelle Radiologie
Aachen, 52074
GermanySite Not Available
HELIOS Klinikum Berlin - Buch
Berlin, 13125
GermanySite Not Available
Universitätsklinikum Essen - Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie - 21197
Essen, 45147
GermanySite Not Available
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
HungarySite Not Available
Flor Ferenc Korhaz
Kistarcsa, 2143
HungarySite Not Available
Kistarcsai Flor Ferenc Korhaz
Kistarcsa, 2143
HungarySite Not Available
BAZMKK es EOK, Kozponti Diagnosztikai Centrum
Miskolc, 3526
HungarySite Not Available
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz, Kozponti Diagnosztikai Centrum
Miskolc, 3526
HungarySite Not Available
Pecsi Tudomanyegyetem Klinikai Kozpont
Pecs, 7625
HungarySite Not Available
Trial Pharma Kft. Szeged
Szeged, 6726
HungarySite Not Available
A.O.U. Sant'Andrea
Roma, Lazio 00189
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Lazio 00168
ItalySite Not Available
ASST Spedali Civili di Brescia
Brescia, Lombardia 25123
ItalySite Not Available
Ospedale San Raffaele s.r.l.
Milano, Lombardia 20132
ItalySite Not Available
ULSS2 Marca Trevigiana
Treviso, Veneto 31100
ItalySite Not Available
Nagoya Tokushukai Genaral Hospital
Kasugai, Aichi 487-0016
JapanSite Not Available
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu, Fukuoka 807-8556
JapanSite Not Available
JCHO Kyushu Hospital
Kitakyushu, Fukuoka 806-8501
JapanSite Not Available
Hokkaido University Hospital
Sapporo, Hokkaido 060-8648
JapanSite Not Available
Hyogo Prefectural Nishinomiya Hospital
Nishinomiya, Hyogo 662-0918
JapanSite Not Available
Public Central Hospital of Matto Ishikawa
Hakusan, Ishikawa 924-8588
JapanActive - Recruiting
Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office
Hakusan, Ishikawa 924-8588
JapanSite Not Available
National Hospital Organization Kanazawa Medical Center
Kanazawa, Ishikawa 920-8650
JapanActive - Recruiting
National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office
Kanazawa, Ishikawa 920-8650
JapanSite Not Available
Takamatsu Red Cross Hospital
Takamatsu, Kagawa 760-0017
JapanSite Not Available
Kishiwada Tokushukai Hospital
Kishiwada, Osaka 596-0042
JapanSite Not Available
Japan Organization of Occupational Health and Safety Sanin Rosai Hospital
Yonago, Tottori 683-8605
JapanSite Not Available
National Hospital Organization Kanmon Medical Center
Shimonoseki, Yamaguchi 752-8510
JapanSite Not Available
Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital
Fukuoka, 811-0213
JapanSite Not Available
Hakodate Central General Hospital
Hakodate, 040-8585
JapanSite Not Available
Hanyu General Hospital
Hanyu, 348-8505
JapanSite Not Available
Osaka City General Hospital
Osaka, 534-0021
JapanSite Not Available
Ajou University Hospital
Suwon, Gyeonggido 443-721
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, Seoul Teugbyeolsi 138-736
Korea, Republic ofSite Not Available
Konkuk University Medical Center
Seoul, Seoul Teugbyeolsi 5030
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi 3080
Korea, Republic ofSite Not Available
Inje University Busan Paik Hospital
Busan, 47392
Korea, Republic ofSite Not Available
NZOZ Kendron
Bialystok, 15-402
PolandSite Not Available
NZOZ Kendron
Białystok,
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
PolandSite Not Available
Centra Medyczne Medyceusz
Lodz, 91-053
PolandSite Not Available
Centrum Medyczne HCP Sp. z o.o.
Poznan, 61-485
PolandSite Not Available
Centrum Medycznym Gamma
Warszawa, 01-785
PolandSite Not Available
Karolinska University Hospital Huddinge Radiology
Stockholm, 14186
SwedenSite Not Available
Akademiska Sjukhuset
Uppsala, 751 85
SwedenSite Not Available
Taipei Medical University - Shuang Ho Hospital
New Taipei City, 23561
TaiwanSite Not Available
Taichung Veterans General Hospital
Taichung, 40705
TaiwanSite Not Available
Chi Mei Medical Center - Medical Imaging Department
Tainan, 71004
TaiwanSite Not Available
Taipei Medical University Hospital - Medical Imaging department
Taipei, 110
TaiwanSite Not Available
Taipei Municipal Wanfang Hospital
Taipei, 116
TaiwanSite Not Available
Tri-Service General Hospital
Taipei,
TaiwanSite Not Available
Tri-Service General Hospital
Taipei City, 114
TaiwanSite Not Available
Lokman Hekim Universitesi Tip Fakultesi - Radyoloji
Ankara, 06510
TurkeySite Not Available
Binali Yildirim Universitesi Mengucek Gazi EAH - Radyoloji
Erzincan, 24610
TurkeySite Not Available
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
Istanbul, 34098
TurkeySite Not Available
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, 34093
TurkeySite Not Available
Koc Universitesi Tip Fakultesi - Radyoloji
Istanbul, 34010
TurkeySite Not Available
Ondokuz Mayis Uni Tip Fakultesi
Samsun, 55139
TurkeySite Not Available
Queen Elizabeth University Hospital
Glasgow, Glasgow City G51 4TF
United KingdomSite Not Available
University Hospital of Wales
Cardiff, CF14 4XW
United KingdomSite Not Available
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
United KingdomSite Not Available
Nottingham University Hospital
Nottingham, NG7 2UH
United KingdomSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesSite Not Available
Halo Diagnostics
Indian Wells, California 92210
United StatesSite Not Available
Biogenix Molecular, LLC
Murrieta, California 92562
United StatesSite Not Available
UC Irvine Medical Center
Orange, California 92868
United StatesSite Not Available
University of Connecticut Health Center
Farmington, Connecticut 06030
United StatesSite Not Available
Biogenix Molecular, LLC
Miami, Florida 33165
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Boston Medical Center
Boston, Massachusetts 02118
United StatesSite Not Available
University of Missouri Hospital and Clinic - Neuroradiology
Columbia, Missouri 65212
United StatesSite Not Available
Duke University School of Medicine
Durham, North Carolina 27710
United StatesSite Not Available
Pennsylvania State University College of Medicine
Hershey, Pennsylvania 17033
United StatesSite Not Available
Houston Methodist Hospital
Houston, Texas 77030
United StatesSite Not Available
University of Wisconsin - Madison
Madison, Wisconsin 53792
United StatesSite Not Available
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