- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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) (Quanti OBR)
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 Any Body Region (Except CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)
Researchers are looking for a better way to help people with any known or suspected problems (except 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 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 known or suspected problems (except brain or spinal cord-related problems) with 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Bayer Clinical Trials Contact
- Phone Number: (+)1-888-84 22937
- Email: clinical-trials-contact@bayer.com
Study Locations
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Córdoba, Argentina, X5000JHQ
- Not yet recruiting
- Sanatorio Allende | Departamento de Investigación Clínica
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Córdoba, Argentina, X5004FHP
- Recruiting
- Clinica Universitaria Reina Fabiola | Consultorios Externos
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Buenos Aires
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Lomas De Zamora, Buenos Aires, Buenos Aires, Argentina, B1832BRQ
- Not yet recruiting
- Fundacion Cientifica del Sur | Centro de Lomas de Zamora - Imaging Interventionism Department
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Ciudad Auton. De Buenos Aires
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Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1425BEE
- Recruiting
- Centro de Diagnóstico Dr. Enrique Rossi
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Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1115AAB
- Recruiting
- Sanatorio Otamendi
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Caba, Ciudad Auton. De Buenos Aires, Argentina, C1426
- Recruiting
- Instituto Alexander Fleming | Sede Central - Departamento de Diagnostico por Imagenes
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Pleven, Bulgaria, 5800
- Recruiting
- University Multiprofile Hospital for Active Treatment Dr Georgi Stranski Pleven | Surgery Department
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Plovdiv, Bulgaria, 4002
- Recruiting
- Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan
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Plovdiv, Bulgaria, 4002
- Recruiting
- University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Imaging Diagnostic Department
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Sofia, Bulgaria, 1431
- Not yet recruiting
- University Multiprofile Hosp. for Active Treat. Sveti Ivan
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Sofia, Bulgaria, 1784
- Not yet recruiting
- University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology Department
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Sofia, Bulgaria, 1407
- Not yet recruiting
- Acibadem City Clinic | University Multiprofile Hospital for Active Treatment Tokuda - Radiology Department
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Sofia, Bulgaria, 1431
- Recruiting
- UMHAT Prof. Dr Aleksandar Chirkov
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Sofia, Bulgaria, 1431
- Recruiting
- UMHAT Alexandrovska EAD
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London, Canada, N6A 5A5
- Not yet recruiting
- London Health Sciences Centre (LHSC) - University Hospital
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Ontario
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London, Ontario, Canada, N6G 2M3
- Not yet recruiting
- St.Joseph's Health Care-London
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Toronto, Ontario, Canada, M5G 2M9
- Withdrawn
- Princess Margaret Hospital-University Health Network
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Quebec
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Montreal, Quebec, Canada, QC H4J 1C5
- Recruiting
- Hôpital du Sacré-Coeur de Montreal
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Beijing, China, 100034
- Recruiting
- Peking University First Hospital
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Beijing, China, 100730
- Recruiting
- Beijing Hospital
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Beijing, China, 100020
- Recruiting
- Beijing Chaoyang Hospital, Capital Medical University
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Guangdong
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Guangzhou, Guangdong, China, 510515
- Recruiting
- Nanfang Hospital, Southern Medical University
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Guangzhou, Guangdong, China, 510630
- Recruiting
- The First Affiliated Hospital of Jinan University
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Jiangsu
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Huai'An, Jiangsu, China, 223300
- Recruiting
- Huai'an First People's Hospital, Nanjing Medical University
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Nanjing, Jiangsu, China, 210009
- Recruiting
- Zhongda Hospital Southeast University
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Sichuan
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Chengdu, Sichuan, China, 610041
- Recruiting
- West China Hospital Sichuan University
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Zhejiang
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Wenzhou, Zhejiang, China, 325000
- Recruiting
- The First Affiliated Hospital of Wenzhou Medical University
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Brno, Czechia, 625 00
- Recruiting
- Fakultni nemocnice Brno
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Ostrava, Czechia, 708 52
- Recruiting
- Fakultní nemocnice Ostrava
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Pardubice, Czechia, 530 03
- Recruiting
- Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
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Plzen-Lochotin, Czechia, 323 00
- Recruiting
- Fakultni nemocnice Plzen - Lochotin
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Prague, Czechia, 140 59
- Recruiting
- Fakultni Thomayerova nemocnice
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Praha 2, Czechia, 12808
- Recruiting
- Vseobecna fakultni nemocnice v Praze
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Angers, France, 49933
- Recruiting
- Centre Hospitalier Universitaire - Angers
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Dijon, France, 21079
- Not yet recruiting
- Centre Hospitalier Universitaire de Dijon
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Lyon, France, 69229
- Recruiting
- Hospices Civils de Lyon
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Paris, France, 75018
- Recruiting
- Hopital Bichat - Paris
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Aachen, Germany, 52074
- Not yet recruiting
- Universitätsklinikum Aachen / Klinik für Diagnostische und Interventionelle Radiologie
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Berlin, Germany, 13125
- Recruiting
- HELIOS Klinikum Berlin - Buch
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Essen, Germany, 45147
- Recruiting
- Universitätsklinikum Essen - Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie - 21197
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Baden-Württemberg
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Freiburg, Baden-Württemberg, Germany, 79106
- Not yet recruiting
- Uniklinik Freiburg / Radiologie
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Niedersachsen
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Göttingen, Niedersachsen, Germany, 37075
- Not yet recruiting
- Universitätsmed Göttingen Institut f. Diag&Interv Radiologie
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Nordrhein-Westfalen
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Bonn, Nordrhein-Westfalen, Germany, 53127
- Recruiting
- Uniklinik Bonn / Radiologie
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Sachsen
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Leipzig, Sachsen, Germany, 04289
- Recruiting
- Helios Herzzentrum Leipzig - Abteilung für Radiologie
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Debrecen, Hungary, 4032
- Recruiting
- Debreceni Egyetem Klinikai Kozpont
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Kistarcsa, Hungary, 2143
- Withdrawn
- Flor Ferenc Korhaz
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Miskolc, Hungary, 3526
- Withdrawn
- Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz, Kozponti Diagnosztikai Centrum
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Pecs, Hungary, 7623
- Recruiting
- Pecsi Tudomanyegyetem Klinikai Kozpont
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Szeged, Hungary, 6726
- Recruiting
- Trial Pharma Kft. Szeged
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Lazio
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Roma, Lazio, Italy, 00168
- Not yet recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Roma, Lazio, Italy, 00189
- Not yet recruiting
- A.O.U. Sant'Andrea
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Lombardia
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Brescia, Lombardia, Italy, 25123
- Recruiting
- ASST Spedali Civili di Brescia
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Milano, Lombardia, Italy, 20132
- Not yet recruiting
- Ospedale San Raffaele s.r.l.
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Veneto
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Treviso, Veneto, Italy, 31100
- Recruiting
- ULSS2 Marca Trevigiana
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Fukuoka, Japan, 811-0213
- Recruiting
- Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital
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Hakodate, Japan, 040-8585
- Recruiting
- Hakodate Central General Hospital
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Hanyu, Japan, 348-8505
- Withdrawn
- Hanyu General Hospital
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Osaka, Japan, 534-0021
- Recruiting
- Osaka City General Hospital
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Aichi
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Kasugai, Aichi, Japan, 487-0016
- Withdrawn
- Nagoya Tokushukai Genaral Hospital
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Fukuoka
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Kitakyushu, Fukuoka, Japan, 806-8501
- Recruiting
- JCHO Kyushu Hospital
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Kitakyushu, Fukuoka, Japan, 807-8556
- Recruiting
- Hospital of the University of Occupational and Environmental Health, Japan
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-8648
- Recruiting
- Hokkaido University Hospital
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Hyogo
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Nishinomiya, Hyogo, Japan, 662-0918
- Recruiting
- Hyogo Prefectural Nishinomiya Hospital
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Ishikawa
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Hakusan, Ishikawa, Japan, 924-8588
- Recruiting
- Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office
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Kanazawa, Ishikawa, Japan, 920-8650
- Recruiting
- National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office
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Kagawa
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Takamatsu, Kagawa, Japan, 760-0017
- Recruiting
- Takamatsu Red Cross Hospital
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Osaka
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Kishiwada, Osaka, Japan, 596-0042
- Recruiting
- Kishiwada Tokushukai Hospital
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Tottori
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Yonago, Tottori, Japan, 683-8605
- Recruiting
- Japan Organization of Occupational Health and Safety Sanin Rosai Hospital
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Yamaguchi
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Shimonoseki, Yamaguchi, Japan, 752-8510
- Recruiting
- National Hospital Organization Kanmon Medical Center
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Busan, Korea, Republic of, 47392
- Not yet recruiting
- Inje University Busan Paik Hospital
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Gyeonggido
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Suwon, Gyeonggido, Korea, Republic of, 443-721
- Not yet recruiting
- Ajou University Hospital
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, Korea, Republic of, 3080
- Recruiting
- Seoul National University Hospital
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Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05030
- Not yet recruiting
- Konkuk University Medical Center
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Seoul, Seoul Teugbyeolsi, Korea, Republic of, 138-736
- Not yet recruiting
- Asan Medical Center
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Bialystok, Poland, 15-402
- Not yet recruiting
- NZOZ Kendron
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Gdansk, Poland, 80-214
- Recruiting
- Uniwersyteckie Centrum Kliniczne
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Lodz, Poland, 91-053
- Recruiting
- Centra Medyczne Medyceusz
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Poznan, Poland, 61-485
- Not yet recruiting
- Centrum Medyczne HCP Sp. z o.o.
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Warszawa, Poland, 01-785
- Withdrawn
- Centrum Medycznym Gamma
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Stockholm, Sweden, 14186
- Recruiting
- Karolinska University Hospital Huddinge Radiology
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Uppsala, Sweden, 751 85
- Recruiting
- Akademiska sjukhuset
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New Taipei City, Taiwan, 23561
- Withdrawn
- Taipei Medical University - Shuang Ho Hospital
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Taichung, Taiwan, 40705
- Withdrawn
- Taichung Veterans General Hospital
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Tainan, Taiwan, 71004
- Withdrawn
- Chi Mei Medical Center - Medical Imaging Department
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Taipei, Taiwan, 110
- Not yet recruiting
- Taipei Medical University Hospital - Medical Imaging department
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Taipei, Taiwan, 116
- Withdrawn
- Taipei Municipal Wanfang Hospital
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Taipei City, Taiwan, 114
- Withdrawn
- Tri-Service General Hospital
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Ankara, Turkey, 06510
- Not yet recruiting
- Lokman Hekim Universitesi Tip Fakultesi - Radyoloji
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Erzincan, Turkey, 24610
- Recruiting
- Binali Yildirim Universitesi Mengucek Gazi EAH - Radyoloji
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Istanbul, Turkey, 34093
- Not yet recruiting
- Istanbul Universitesi Istanbul Tip Fakultesi
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Istanbul, Turkey, 34098
- Not yet recruiting
- Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
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Istanbul, Turkey, 34010
- Recruiting
- Koc Universitesi Tip Fakultesi - Radyoloji
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Samsun, Turkey, 55139
- Recruiting
- Ondokuz Mayis Uni Tip Fakultesi
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Cardiff, United Kingdom, CF14 4XW
- Not yet recruiting
- University Hospital of Wales
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Edinburgh, United Kingdom, EH16 4SA
- Withdrawn
- Royal Infirmary of Edinburgh
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Nottingham, United Kingdom, NG7 2UH
- Recruiting
- Nottingham University Hospital
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Glasgow City
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Glasgow, Glasgow City, United Kingdom, G51 4TF
- Recruiting
- Queen Elizabeth University Hospital
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Alabama
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Birmingham, Alabama, United States, 35233
- Not yet recruiting
- University of Alabama at Birmingham
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California
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Indian Wells, California, United States, 92210
- Recruiting
- Halo Diagnostics
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Murrieta, California, United States, 92562
- Not yet recruiting
- Biogenix Molecular, LLC
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Orange, California, United States, 92868
- Not yet recruiting
- UC Irvine Medical Center
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Connecticut
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Farmington, Connecticut, United States, 06030
- Not yet recruiting
- University of Connecticut Health Center
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Illinois
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Chicago, Illinois, United States, 60611
- Not yet recruiting
- Northwestern University
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Not yet recruiting
- Boston Medical Center
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Missouri
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Columbia, Missouri, United States, 65212
- Recruiting
- University of Missouri Hospital and Clinic - Neuroradiology
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North Carolina
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Durham, North Carolina, United States, 27710
- Not yet recruiting
- Duke University School of Medicine
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Not yet recruiting
- Pennsylvania State University College of Medicine
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Texas
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Houston, Texas, United States, 77030
- Not yet recruiting
- Houston Methodist Hospital
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Wisconsin
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Madison, Wisconsin, United States, 53792
- Withdrawn
- University of Wisconsin - Madison
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 magnetic resonance angiography [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, with known or suspected pathology of any body region, e.g. head and neck (except central nervous system [CNS]), thorax (including e.g. breast, heart, chest wall), abdomen (including e.g. liver, kidney, pancreas), pelvis (including e.g. prostate, uterus, ovaries), extremities (including upper and lower.
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gadoquatrane - Approved Macrocyclic GBCA
Participants will receive one intravenous injection of gadoquatrane during MRI in Period 1, followed by one intravenous injection of any approved macrocyclic GBCA during MRI in Period 2.
|
0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose
Other Names:
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 during MRI in Period 1, followed by one intravenous injection of gadoquatrane during MRI in Period 2.
|
0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose
Other Names:
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 day procedure
|
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
|
1 day procedure
|
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
|
1 day procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
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
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
|
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
Time Frame: 1 day procedure
|
BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
|
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
Time Frame: 1 day procedure
|
BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
|
1 day procedure
|
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
|
1 day procedure
|
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
|
1 day procedure
|
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
|
1 day procedure
|
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
|
1 day procedure
|
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
|
1 day procedure
|
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
|
1 day procedure
|
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
|
Within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic GBCAs
|
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
|
Within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic GBCAs
|
Confidence in diagnosis combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs by BICR and by Investigator
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
|
1 day procedure
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21197
- 2022-501885-24-00 (Other Identifier: CTIS (EU))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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