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
- Conditions
- Central Nervous System PathologyContrast Enhancement in Magnetic Resonance Imaging
- Interventions
- Registration Number
- NCT05915702
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 303
- 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 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, for a known or suspected CNS pathology
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Gadoquatrane - Approved Macrocyclic GBCA Gadoquatrane (BAY1747846) Participants will receive one intravenous injection of gadoquatrane before or during MRI in Period 1, followed by one intravenous injection of any approved macrocyclic GBCA before or during MRI in Period 2. Gadoquatrane - Approved Macrocyclic GBCA Gadoterate meglumine Participants will receive one intravenous injection of gadoquatrane before or during MRI in Period 1, followed by one intravenous injection of any approved macrocyclic GBCA before or during MRI in Period 2. Gadoquatrane - Approved Macrocyclic GBCA Gadobutrol Participants will receive one intravenous injection of gadoquatrane before or during MRI in Period 1, followed by one intravenous injection of any approved macrocyclic GBCA before or during MRI in Period 2. Approved Macrocyclic GBCA - Gadoquatrane Gadoquatrane (BAY1747846) Participants will receive one intravenous injection of any approved macrocyclic GBCA before or during MRI in Period 1, followed by one intravenous injection of gadoquatrane before or during MRI in Period 2. Approved Macrocyclic GBCA - Gadoquatrane Gadoterate meglumine Participants will receive one intravenous injection of any approved macrocyclic GBCA before or during MRI in Period 1, followed by one intravenous injection of gadoquatrane before or during MRI in Period 2. Gadoquatrane - Approved Macrocyclic GBCA Gadoteridol Participants will receive one intravenous injection of gadoquatrane before or during MRI in Period 1, followed by one intravenous injection of any approved macrocyclic GBCA before or during MRI in Period 2. Approved Macrocyclic GBCA - Gadoquatrane Gadobutrol Participants will receive one intravenous injection of any approved macrocyclic GBCA before or during MRI in Period 1, followed by one intravenous injection of gadoquatrane before or during MRI in Period 2. Approved Macrocyclic GBCA - Gadoquatrane Gadoteridol Participants will receive one intravenous injection of any approved macrocyclic GBCA before or during MRI in Period 1, followed by one intravenous injection of gadoquatrane before or during MRI in Period 2.
- Primary Outcome Measures
Name Time Method Visualization parameter delineation assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR 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
Visualization parameter contrast Enhancement assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR 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
Visualization parameter morphology assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR 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
- Secondary Outcome Measures
Name Time Method 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 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
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 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
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 1 day procedure BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
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 1 day procedure BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
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 1 day procedure BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
The overall diagnostic clinical value of combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs 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
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 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
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 Within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic GBCAs GBCAs = gadolinium-based contrast agents
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 1 day procedure BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
Diagnoses from combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs by the Investigator 1 day procedure BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
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 1 day procedure BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
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 4PS 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
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 1 day procedure BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
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 Within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic GBCAs GBCAs = gadolinium-based contrast agents
Trial Locations
- Locations (78)
Fakultni nemocnice Plzen - Lochotin
🇨🇿Plzen, Czechia
Szent Damjan Gorogkatolikus Korhaz
🇭🇺Kisvarda, Hungary
Idegsebeszeti Klinika
🇭🇺Pecs, Hungary
Trial Pharma Kft. Szeged
🇭🇺Szeged, Hungary
Karolinska University Hospital, Solna Neuroradiology
🇸🇪Stockholm, Sweden
Uppsala University Hospital, Neuroradiology Department
🇸🇪Uppsala, Sweden
Hacettepe Universitesi Tip Fakultesi
🇹🇷Ankara, Turkey
Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
🇯🇵Osaka, Japan
Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan
🇧🇬Plovdiv, Bulgaria
Halo Diagnostics - Indian Wells
🇺🇸Indian Wells, California, United States
University of California Irvine Med. Center / Diagnostic Radiology, Neuroradiology
🇺🇸Orange, California, United States
Biogenix Molecular, LLC
🇺🇸Miami, Florida, United States
Northwestern Memorial Hospital - Radiology
🇺🇸Chicago, Illinois, United States
QUEST Research Institute | Farmington Hills, MI
🇺🇸Farmington Hills, Michigan, United States
University of Missouri -Radiology - Columbia
🇺🇸Columbia, Missouri, United States
Duke University School of Medicine - Early Phase Research Unit - Neurology
🇺🇸Durham, North Carolina, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Fundacion Cientifica del Sur | Centro de Lomas de Zamora - Imaging Interventionism Department
🇦🇷Lomas De Zamora, Buenos Aires, Buenos Aires, Argentina
Instituto Alexander Fleming | Sede Central - Departamento de Diagnostico por Imagenes
🇦🇷Caba, Ciudad Auton. De Buenos Aires, Argentina
Sanatorio Otamendi | Imaging Diagnostic Center
🇦🇷Ciudad Autonoma de Buenos Aire, Ciudad Auton. De Buenos Aires, Argentina
Centro de Diagnostico Enrique Rossi | Departamento de Investigacion Clínica
🇦🇷Ciudad Autonoma de Buenos Aire, Ciudad Auton. De Buenos Aires, Argentina
Clinica Universitaria Reina Fabiola | Consultorios Externos
🇦🇷Cordoba, Argentina
Sanatorio Allende | Departamento de Investigación Clínica
🇦🇷Córdoba, Argentina
University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Imaging Diagnostic Department
🇧🇬Plovdiv, Bulgaria
Acibadem City Clinic Multiprofile Hospital for Active Treatm
🇧🇬Sofia, Bulgaria
University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD
🇧🇬Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment Prof. Dr. Alexander Chirkov EAD
🇧🇬Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Radiology Department
🇧🇬Sofia, Bulgaria
University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology Department
🇧🇬Sofia, Bulgaria
MHAT Sveta Marina EAD
🇧🇬Varna, Bulgaria
Hopital du Sacre-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
London Health Sciences Centre (LHSC) - University Hospital
🇨🇦London, Canada
Beijing Chaoyang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Beijing Tiantan Hospital, Captial Medical University
🇨🇳Beijing, Beijing, China
Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan University
🇨🇳Guangzhou, Guangdong, China
Huai'an First People's Hospital, Nanjing Medical University
🇨🇳Huai'An, Jiangsu, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Fakultní nemocnice Brno - Klinika radiologie a nukleární medicíny
🇨🇿Brno, Jihomoravsky Kraj, Czechia
Fakultní nemocnice Ostrava
🇨🇿Ostrava - Poruba, Czechia
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
🇨🇿Pardubice, Czechia
Fakultní Thomayerova nemocnice - RDG radiodiagnostické oddelení
🇨🇿Praha 4, Czechia
Všeobecná fakultní nemocnice v Praze
🇨🇿Praha, Czechia
Center Hospitalier Michallon - Grenoble
🇫🇷Grenoble Cedex 09, France
Centre Hospitalier Lyon Sud - Service d'imagerie
🇫🇷Pierre-Benite, France
Centre Hospitalo-Universitaire de Strasbourg
🇫🇷Strasbourg, France
Uniklinik Augsburg / Radiologie
🇩🇪Augsburg, Bayern, Germany
Universitätsklinikum Essen - Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie - 21181
🇩🇪Essen, Nordrhein-Westfalen, Germany
St. Franziskus-Hospital GmbH
🇩🇪Münster, Nordrhein-Westfalen, Germany
Uniklinik Kiel /Radiologie und Neuroradiologie
🇩🇪Kiel, Schleswig-Holstein, Germany
Debreceni Egyetem Klinikai Kozpont, Idegsebeszeti Klinika
🇭🇺Debrecen, Hungary
Azienda Ospedaliero-Universitaria Sant'Andrea - UOC Neuroradiologia
🇮🇹Roma, Lazio, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Radiologia diagnostica per immagini 2 Neuroradiologia
🇮🇹Bergamo, Lombardia, Italy
ASL Della Provincia Di Barletta Andria Trani_Ospedale L.Bonomo - Radiodiagnostica
🇮🇹Andria, Puglia, Italy
Kure Kyosai Hospital
🇯🇵Kure, Hiroshima, Japan
Hyogo Prefectural Nishinomiya Hospital
🇯🇵Nishinomiya, Hyogo, Japan
National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office
🇯🇵Kanazawa, Ishikawa, Japan
Japan Organization of Occupational Health and Safety Kagawa Rosai Hospital
🇯🇵Marugame, Kagawa, Japan
Shonan Fujisawa Tokushukai Hospital
🇯🇵Fujisawa, Kanagawa, Japan
Kishiwada Tokushukai Hospital
🇯🇵Kishiwada, Osaka, Japan
National Hospital Organization Kanmon Medical Center
🇯🇵Shimonoseki, Yamaguchi, Japan
National Hospital Organization Kyushu Medical Center
🇯🇵Fukuoka, Japan
Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital
🇯🇵Fukuoka, Japan
Konkuk University Medical Center
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Karolinska University Hospital, Huddinge Neuroradiology
🇸🇪Stockholm, Sweden
Binali Yildirim Universitesi Mengucek Gazi EAH - Radyoloji
🇹🇷Erzincan, Turkey
Koc Universitesi Tip Fakultesi - Radyoloji
🇹🇷Istanbul, Turkey
Istanbul Universitesi Istanbul Tip Fakultesi
🇹🇷Istanbul, Turkey
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
🇹🇷Istanbul, Turkey
Ondokuz Mayis Uni Tip Fakultesi
🇹🇷Samsun, Turkey
Queen Elizabeth University Hospital
🇬🇧Glasgow, Glasgow City, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Charing Cross Hospital
🇬🇧London, United Kingdom