check_circleStudy Completed
Contrast enhancement in magnetic resonance imaging, Non-central nervous system pathology
Bayer Identifier:
21197
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
2022-501885-24-00
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)
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
404Trial Dates
July 2023 - June 2024Phase
Phase 3Could I Receive a placebo
NoProducts
Gadoquatrane (BAY1747846)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | The First Affiliated Hospital of Wenzhou Medical University | Wenzhou, 325000, China |
Completed | The First Affiliated Hospital of Jinan University | Guangzhou, 510630, China |
Completed | Nanfang Hospital, Southern Medical University | Guangzhou, 510515, China |
Completed | Centro de Diagnostico Enrique Rossi | Departamento de Investigacion Clínica | Ciudad Autonoma de Buenos Aire, C1425BEE, Argentina |
Completed | Sanatorio Allende | Departamento de Investigación Clínica | Córdoba, X5000JHQ, Argentina |
Completed | Fundacion Cientifica del Sur | Centro de Lomas de Zamora - Imaging Interventionism Department | Lomas de Zamora, Buenos Aires, B1832BRQ, Argentina |
Completed | Sanatorio Otamendi | Imaging Diagnostic Center | Ciudad Autonoma de Buenos Aire, C1115AAB, Argentina |
Completed | Clinica Universitaria Reina Fabiola | Consultorios Externos | Cordoba, X5004FHP, Argentina |
Completed | Instituto Alexander Fleming | Sede Central - Departamento de Diagnostico por Imagenes | CABA, C1426, Argentina |
Completed | Beijing Hospital | Beijing, 100730, China |
Completed | Beijing Chaoyang Hospital, Capital Medical University | Beijing, 100020, China |
Completed | Seoul National University Hospital | Seoul, 3080, Korea,_republic_of |
Withdrawn | Asan Medical Center | Seoul, 05505, Korea,_republic_of |
Withdrawn | Konkuk University Medical Center | Seoul, 05030, Korea,_republic_of |
Completed | Ajou University Hospital | Suwon-si, 16499, Korea,_republic_of |
Not yet recruiting | Centrum Medycznym Gamma | Warszawa, 01-785, Poland |
Withdrawn | Centrum Medyczne HCP Sp. z o.o. | Poznan, 61-485, Poland |
Completed | Uniwersyteckie Centrum Kliniczne | Gdansk, 80-214, Poland |
Completed | Centra Medyczne Medyceusz | Lodz, 91-053, Poland |
Completed | Queen Elizabeth University Hospital | Glasgow, G51 4TF, United Kingdom |
Withdrawn | Royal Infirmary of Edinburgh | Edinburgh, EH16 4SA, United Kingdom |
Completed | University Hospital of Wales | Cardiff, CF14 4XW, United Kingdom |
Completed | Nottingham University Hospital | Nottingham, NG7 2UH, United Kingdom |
Completed | Trial Pharma Kft. Szeged | Szeged, 6726, Hungary |
Completed | Pecsi Tudomanyegyetem Klinikai Kozpont | Pecs, 7625, Hungary |
Withdrawn | Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz, Kozponti Diagnosztikai Centrum | Miskolc, 3526, Hungary |
Withdrawn | Kistarcsai Flor Ferenc Korhaz | Kistarcsa, 2143, Hungary |
Completed | Fakultni nemocnice Plzen - Lochotin | Plzen, 32300, Czech Republic |
Completed | Všeobecná fakultní nemocnice v Praze | Praha 2, 12808, Czech Republic |
Completed | Fakultní nemocnice Ostrava - Radiodiagnostický ústav | Ostrava, 708 00, Czech Republic |
Completed | Fakultní Thomayerova nemocnice - klinicko-farmakologická jednotka | Praha 4 - Krc, 140 00, Czech Republic |
Completed | Fakultní nemocnice Brno - Klinika radiologie a nukleární medicíny | Brno, 625 00, Czech Republic |
Completed | Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice | Pardubice, 530 03, Czech Republic |
Completed | University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD | Sofia, 1431, Bulgaria |
Withdrawn | Ospedale San Raffaele s.r.l. - Radiologia Diagnostica | Milano, 20132, Italy |
Completed | Azienda Ospedaliero-Universitaria Sant'Andrea - UOC Radiologia | Roma, 00189, Italy |
Completed | Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - Radiologia Diagnostica 1 | Brescia, 25123, Italy |
Completed | AULSS N. 2 Marca Trevigiana_Ospedale di Treviso - UOC Radiologia | Treviso, 31100, Italy |
Terminated | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma, 00168, Italy |
Completed | University of Alabama at Birmingham | Birmingham, 35233, United States |
Completed | University of Missouri Hospital and Clinic – Neuroradiology | Columbia, 65212, United States |
Not yet recruiting | University of Connecticut Health Center | Farmington, 06032, United States |
Not yet recruiting | UC Irvine Medical Center | Orange, 92868, United States |
Completed | Halo Diagnostics - Indian Wells | Indian Wells, 92210, United States |
Not yet recruiting | Pennsylvania State University College of Medicine | Hershey, 17033, United States |
Completed | Duke University School of Medicine - Early Phase Research Unit - Neurology | Durham, 27710, United States |
Completed | Houston Methodist Hospital - Cardiology | Houston, 77030, United States |
Withdrawn | Boston Medical Center - Oncology | Boston, 02118, United States |
Withdrawn | Northwestern University | Chicago, 60611, United States |
Completed | Hokkaido University Hospital | Sapporo, 060-8648, Japan |
Completed | National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office | Kanazawa, 920-8650, Japan |
Completed | Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office | Hakusan, 924-8588, Japan |
Withdrawn | Nagoya Tokushukai Genaral Hospital | Kasugai, 487-0016, Japan |
Completed | Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital | Osaka, 534-0021, Japan |
Completed | Hyogo Prefectural Nishinomiya Hospital | Nishinomiya, 662-0918, Japan |
Completed | National Hospital Organization Kanmon Medical Center | Shimonoseki, 752-8510, Japan |
Completed | Takamatsu Red Cross Hospital | Takamatsu, 760-0017, Japan |
Completed | Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital | Fukuoka, 811-0213, Japan |
Completed | Hospital of the University of Occupational and Environmental Health, Japan | Kitakyushu, 807-8556, Japan |
Completed | JCHO Kyushu Hospital | Kitakyushu, 806-8501, Japan |
Completed | Kishiwada Tokushukai Hospital | Kishiwada, 596-0042, Japan |
Completed | Japan Organization of Occupational Health and Safety Sanin Rosai Hospital | Yonago, 683-8605, Japan |
Completed | West China Hospital Sichuan University | Chengdu, 610041, China |
Completed | Karolinska University Hospital Huddinge Radiology | Stockholm, 14186, Sweden |
Completed | University Multiprofile Hospital for Active Treatment Prof. Dr. Alexander Chirkov EAD | Sofia, 1431, Bulgaria |
Terminated | University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Radiology Department | Sofia, 1431, Bulgaria |
Not yet recruiting | Acibadem City Clinic | University Multiprofile Hospital for Active Treatment Tokuda - Radiology Department | Sofia, 1407, Bulgaria |
Not yet recruiting | University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology Department | Sofia, 1784, Bulgaria |
Completed | University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Imaging Diagnostic Department | Plovdiv, 4002, Bulgaria |
Completed | Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan | Plovdiv, 4002, Bulgaria |
Completed | Peking University First Hospital | Beijing, 100034, China |
Withdrawn | University of Wisconsin - Madison | Madison, 53792, United States |
Withdrawn | Princess Margaret Hospital-University Health Network | Toronto, M5G 2M9, Canada |
Completed | Hopital du Sacre-Coeur de Montreal | Montreal, QC H4J 1C5, Canada |
Withdrawn | St.Joseph's Health Care-London | London, N6A 4V2, Canada |
Completed | Huai'an First People's Hospital, Nanjing Medical University | Huai'An, 223300, China |
Completed | Zhongda Hospital Southeast University | Nanjing, 210009, China |
Completed | Binali Yildirim Universitesi Mengucek Gazi EAH - Radyoloji | Erzincan, 24100, Turkey |
Completed | Istanbul Universitesi Istanbul Tip Fakultesi | Istanbul, 34093, Turkey |
Completed | Koc Universitesi Tip Fakultesi - Radyoloji | Istanbul, 34010, Turkey |
Withdrawn | Lokman Hekim Universitesi Tip Fakultesi - Radyoloji | Ankara, 06930, Turkey |
Completed | Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi | Istanbul, 34098, Turkey |
Completed | Ondokuz Mayis Uni Tip Fakultesi | Samsun, 55139, Turkey |
Completed | University Multiprofile Hospital for Active Treatment Dr Georgi Stranski Pleven | Surgery Department | Pleven, 5809, Bulgaria |
Completed | Universitätsmedizin Göttingen - Institut für Diagnostische und Interventionelle Radiologie | Göttingen, 37075, Germany |
Completed | Helios Herzzentrum Leipzig - Abteilung für Radiologie | Leipzig, 04289, Germany |
Completed | Uniklinik Freiburg / Radiologie | Freiburg, 79106, Germany |
Completed | Uniklinik Bonn / Radiologie | Bonn, 53127, Germany |
Completed | Universitätsklinikum Essen - Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie - 21197 | Essen, 45147, Germany |
Completed | Helios Klinikum Berlin-Buch - Klinik für Kardiologie - Kardio MRT | Berlin, 13125, Germany |
Withdrawn | Universitätsklinikum Aachen / Klinik für Diagnostische und Interventionelle Radiologie | Aachen, 52074, Germany |
Completed | Debreceni Egyetem - Klinikai Kozpont - Onkologiai Klinika | Debrecen, 4032, Hungary |
Completed | Centre Hospitalier Universitaire - Angers | Angers, 49933, France |
Completed | Hospices Civils de LYON | Bron, 69500, France |
Completed | Hôpital Bichat Claude Bernard - Service de radiologie | Paris, 75018, France |
Completed | Centre Hospitalier Universitaire de Dijon | Dijon, 21079, France |
Completed | Akademiska Sjukhuset | Uppsala, 751 85, Sweden |
Withdrawn | Taipei Medical University Hospital - Medical Imaging department | Taipei, 110, Taiwan |
Withdrawn | Chi Mei Medical Center - Medical Imaging Department | Tainan, 71004, Taiwan |
Withdrawn | Taipei Municipal Wanfang Hospital | Taipei City, 116, Taiwan |
Withdrawn | Taichung Veterans General Hospital | Taichung, 40705, Taiwan |
Withdrawn | Tri-Service General Hospital | Taipei, 114, Taiwan |
Withdrawn | Taipei Medical University - Shuang Ho Hospital | New Taipei City, 23561, Taiwan |
Withdrawn | London Health Sciences Centre (LHSC) - University Hospital | London, N6A 5A5, Canada |
Completed | NZOZ Kendron | Bialystok, 15-402, Poland |
Completed | Hakodate Central General Hospital | Hakodate, 040-8585, Japan |
Withdrawn | Hanyu General Hospital | Hanyu, 348-8505, Japan |
Withdrawn | Inje University Busan Paik Hospital | Busan, 47392, Korea,_republic_of |
Completed | Biogenix Molecular, LLC | Miami, 33165, United States |
Primary Outcome
- Visualization parameter contrast Enhancement assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICRContrast 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 imagingdate_rangeTime Frame:1 day procedure
- Visualization parameter delineation assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICRDelineation 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 imagingdate_rangeTime Frame:1 day procedure
- Visualization parameter morphology assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICRMorphology 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 imagingdate_rangeTime Frame:1 day procedure
Secondary Outcome
- 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 BICRContrast 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 agentsdate_rangeTime Frame: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 BICRDelineation 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 agentsdate_rangeTime Frame: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 BICRMorphology 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 agentsdate_rangeTime Frame: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 BICRBICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agentsdate_rangeTime Frame: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 BICRBICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agentsdate_rangeTime Frame:1 day procedure
- The overall diagnostic clinical value of combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAsThe 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 imagingdate_rangeTime Frame: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 investigatorBICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agentsdate_rangeTime Frame: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 investigatorBICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agentsdate_rangeTime Frame:1 day procedure
- Diagnoses from combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs by the InvestigatorBICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agentsdate_rangeTime Frame:1 day procedure
- Confidence in diagnosis combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs by BICR and by InvestigatorThe 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 agentsdate_rangeTime Frame: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 BICRBICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agentsdate_rangeTime Frame: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 BICRBICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agentsdate_rangeTime Frame: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 investigatorGBCAs = gadolinium-based contrast agentsdate_rangeTime Frame: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 investigatorGBCAs = gadolinium-based contrast agentsdate_rangeTime Frame:Within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic GBCAs
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
RandomizedBlinding
N/AAssignment
Crossover AssignmentTrial Arms
2