check_circleStudy Completed
Contrast enhancement in magnetic resonance imaging, Central nervous system pathology
Bayer Identifier:
21181
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
2022-501884-41-00
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
Trial purpose
Researchers are looking for a better way to help people with known or suspected 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 a 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 brain and spinal cord-related problems in 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 a 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 brain and spinal cord-related problems in 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
303Trial Dates
July 2023 - May 2024Phase
Phase 3Could I Receive a placebo
NoProducts
Gadoquatrane (BAY1747846)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | SUN YAT-SEN MEMORIAL HOSP. SUN YAT-SEN UNIV. | Guangzhou, 510120, China |
Completed | UMHAT Alexandrovska EAD | Sofia, 1431, Bulgaria |
Completed | Centro de Diagnóstico Dr. Enrique Rossi | Buenos Aires, C1425BEE, Argentina |
Completed | Sanatorio Allende | Departamento de Investigación Clínica | Córdoba, X5000JHQ, Argentina |
Active, not recruiting | 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 | Buenos Aires, C1115AAB, Argentina |
Completed | Clinica Universitaria Reina Fabiola | Consultorios Externos | Cordoba, X5004FHP, Argentina |
Completed | Beijing Tiantan Hospital, Captial Medical University | Beijing, 100050, China |
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 |
Active, not recruiting | Beijing Chaoyang Hospital, Capital Medical University | Beijing, 100020, China |
Completed | Seoul National University Hospital | Seoul, 3080, Korea, Republic Of |
Withdrawn | Asan Medical Center | Seoul, 138-736, Korea, Republic Of |
Completed | Konkuk University Medical Center | Seoul, 5030, Korea, Republic Of |
Withdrawn | Ajou University Hospital | Suwon, 443-721, Korea, Republic Of |
Active, not recruiting | Charing Cross Hospital | London, W6 8RF, United Kingdom |
Completed | Trial Pharma Kft. Szeged | Szeged, 6726, Hungary |
Completed | Idegsebeszeti Klinika | Pecs, 7623, Hungary |
Completed | Debreceni Egyetem Klinikai Kozpont, Idegsebeszeti Klinika | Debrecen, 4032, Hungary |
Withdrawn | Kistarcsai Flor Ferenc Korhaz | Kistarcsa, 2143, Hungary |
Withdrawn | Semmelweis Egyetem Idegsebeszeti es Neurointervencios Klinika | Budapest, 1145, Hungary |
Completed | Szent Damjan Gorogkatolikus Korhaz | Kisvarda, 4600, Hungary |
Completed | Queen Elizabeth University Hospital | Glasgow, G51 4TF, United Kingdom |
Withdrawn | Royal Infirmary of Edinburgh | Edinburgh, EH16 4SA, United Kingdom |
Not yet recruiting | University Hospital of Wales | Cardiff, CF14 4XW, United Kingdom |
Completed | Fakultni nemocnice Plzen - Lochotin | Plzen, 32300, Czechia |
Completed | Vseobecna fakultni nemocnice v Praze | Praha 2, 12808, Czechia |
Completed | Fakultni nemocnice Ostrava | Ostrava, 708 52, Czechia |
Completed | Fakultni Thomayerova Nemocnice | Prague, 140 59, Czechia |
Withdrawn | Medical University of South Carolina - Radiology | Charleston, 29425, United States |
Completed | University of Missouri -Radiology - Columbia | Columbia, 65212, United States |
Withdrawn | University of Connecticut Health Center | Farmington, 06032, United States |
Withdrawn | University of California Irvine Med. Center / Diagnostic Radiology, Neuroradiology | Orange, 92868, United States |
Completed | Halo Diagnostics | Indian Wells, 92210, United States |
Withdrawn | Penn State Milton S. Hershey Medical Center | Hershey, 17033, United States |
Completed | QUEST Research Institute | Farmington Hills, MI | Farmington Hills, 48334, United States |
Completed | Northwestern University - Dept. of Radiology | Chicago, 60611, United States |
Completed | Fakultni nemocnice Brno | Brno, 625 00, Czechia |
Withdrawn | Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice | Pardubice, 530 03, Czechia |
Completed | Instituto Alexander Fleming | Sede Central - Departamento de Diagnostico por Imagenes | CABA, C1426, Argentina |
Withdrawn | Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz, Kozponti Diagnosztikai Centrum | Miskolc, 3526, Hungary |
Completed | ASST Papa Giovanni XXIII | Bergamo, 24127, Italy |
Withdrawn | Ospedale San Raffaele s.r.l. | Milano, 20132, Italy |
Completed | A.O.U. Sant'Andrea | Roma, 00189, Italy |
Completed | ASL Provincia di Barletta-Andria-Trani | Andria, 70031, Italy |
Completed | Uniklinik Kiel /Radiologie und Neuroradiologie | Kiel, 24105, Germany |
Completed | Universitätsklinikum Essen | Essen, 45122, Germany |
Completed | St. Franziskus-Hospital GmbH | Münster, 48145, Germany |
Completed | Uniklinik Augsburg / Radiologie | Augsburg, 86156, Germany |
Withdrawn | University of Texas Southwestern Medical Center | Dallas, 75235-3858, United States |
Completed | Uppsala University Hospital, Neuroradiology Department | Uppsala, 75185, Sweden |
Completed | Karolinska University Hospital, Huddinge Neuroradiology | Stockholm, 141 86, Sweden |
Completed | Karolinska University Hospital, Solna Neuroradiology | Stockholm, 17177, Sweden |
Completed | University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Radiology Department | Sofia, 1431, Bulgaria |
Completed | University Multiprofile Hospital for Active Treatment Prof. Dr. Alexander Chirkov EAD | Sofia, 1431, Bulgaria |
Withdrawn | Acibadem City Clinic Multiprofile Hospital for Active Treatm | Sofia, 1407, Bulgaria |
Completed | UMHAT Tsaritsa Joanna-ISUL EAD Sofia | Sofia, 1606, Bulgaria |
Completed | University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Imaging Diagnostic Department | Plovdiv, 4002, Bulgaria |
Completed | MHAT Sveta Marina EAD | Varna, 9010, 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 |
Completed | Osaka City General Hospital | Osaka, 534-0021, Japan |
Completed | Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital | Fukuoka, 811-0213, Japan |
Completed | National Hospital Organization Kyushu Medical Center | Fukuoka, 810-8563, Japan |
Withdrawn | Hospital of the University of Occupational and Environmental Health, Japan | Kitakyushu, 807-8556, Japan |
Withdrawn | Hokkaido University Hospital | Sapporo, 060-8648, Japan |
Completed | Shonan Fujisawa Tokushukai Hospital | Fujisawa, 251-0041, Japan |
Completed | National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office | Kanazawa, 920-8650, Japan |
Withdrawn | Princess Margaret Hospital-University Health Network | Toronto, M5G 2M9, Canada |
Active, not recruiting | Hopital du Sacre-Coeur de Montreal | Montreal, QC H4J 1C5, Canada |
Withdrawn | St.Joseph's Health Care-London | London, N6G 2M3, Canada |
Completed | Japan Organization of Occupational Health and Safety Kagawa Rosai Hospital | Marugame, 763-8502, Japan |
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, 24610, 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, 06510, Turkey |
Completed | Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi | Istanbul, 34098, Turkey |
Not yet recruiting | Hacettepe Universitesi Tip Fakultesi | Ankara, 06532, Turkey |
Not yet recruiting | Ondokuz Mayis Uni Tip Fakultesi | Samsun, 55139, Turkey |
Completed | Kishiwada Tokushukai Hospital | Kishiwada, 596-0042, Japan |
Completed | Centre Hospitalier Lyon Sud | PIERRE BENITE, 69495, France |
Completed | Center Hospitalier Michallon - Grenoble | LA TRONCHE, 38700, France |
Completed | CHU STRASBOURG - Hôpital de Hautepierre | STRASBOURG CEDEX, 67098, France |
Completed | Hyogo Prefectural Nishinomiya Hospital | Nishinomiya, 662-0918, Japan |
Completed | Kure Kyosai Hospital | Kure, 737-8505, Japan |
Completed | National Hospital Organization Kanmon Medical Center | Shimonoseki, 752-8510, Japan |
Withdrawn | Mayo Clinic - Rochester | Rochester, 55905, United States |
Completed | London Health Sciences Centre (LHSC) - University Hospital | London, N6A 5A5, Canada |
Completed | Duke University School of Medicine | Durham, 27710, United States |
Completed | 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 Investigator on 4PSThe 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