Trial Condition(s):
Study to find the appropriate dose of a new gadolinium-based contrast agent (GBCA) for adults undergoing magnetic resonance imaging (MRI) for known or highly suspected brain and/or spinal cord conditions
20241
Not Available
Researchers in this study want to find the appropriate dose of drug BAY1747846 for adults undergoing MRI for known or highly suspected brain and/or spinal cord conditions so that the image quality is similar to that of drug gadobutrol for adults undergoing MRI. MRI stands for Magnetic resonance imaging which produces body pictures created by using magnetic energy rather than x-ray energy.
Both BAY1747846 and gadobutrol are medicinal products known as gadolinium-based contrast agents (GBCA) which are used in MRI examinations to provide contrast enhancement and improve imaging performance. Gadobutrol (brand name: Gadavist, Gadovist) has been approved worldwide for the diagnosis of various disorders in adult and pediatric patients. BAY1747846 is a new GBCA under development with the goal to provide similar imaging performances in MRI. Participants in this study will receive both BAY1747846 and gadobutrol with a period of 3 - 14 days in between. A MRI examination will be performed after each injection. Participant will stay in this study for 2 - 4 weeks depending on the scheduling of the visits.
- Participant must be at least 18 years of age at the time of signing the informed consent. - Known or highly suspected CNS pathology (contrast-enhancing CNS lesion) referred for contrast-enhanced MRI of the CNS. - Male and female. - Estimated glomerular filtration rate (eGFR) value ≥60 mL/min/1.73m^2.
- Considered clinically unstable. - Severe cardiovascular disease. - Any contraindication to MRI examinations. - History of severe allergic or anaphylactic/anaphylactoid reaction to any allergen including drugs and contrast agents. - History of allergic asthma. - Suspected lesions or suffering from any of the following CNS diseases/lesion types as the main indication for MRI: -- Meningeal disease (focal enhancement) -- Pituitary adenomas (macro and micro) -- Tumors of the choroid plexus -- Tumors of the pineal gland -- Dermoid/epidermoid tumors -- Infectious disease (e.g. brain abscess, cisticercosis, etc.) -- Venous angiomas -- Subacute/chronic ischemia -- Encephalitis -- Multiple sclerosis (acute and chronic) -- Optic neuritis -- Chordomas -- Von Hippel Lindau syndrome -- Hypertensive leukoencephalopathy. - Receipt of any contrast agent <72 h prior to the study MRIs, or planned receipt of any contrast agent within 72 h after the second study MRI. - Planned or expected biopsy or any interventional therapeutic procedure from the first study MRI up to 24 h after the second study MRI. - Planned or expected change in any treatment or procedure between the two study MRIs that may alter image comparability and /or chemotherapy which is changed between the two MRI procedures. - Contraindications to the administration of gadobutrol (depending on local product label).
Locations | Status | |
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Locations Universitätsklinikum Essen Essen, Germany, 45147 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Iowa Hospitals & Clinics Iowa City, United States, 52242-1089 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Massachusetts General Hospital Boston, United States, 02114-2696 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Schleswig-Holstein (UKSH) Kiel, Germany, 24105 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Washington Seattle, United States, 98104 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cedars- Sinai Medical Center Los Angeles, United States, 90048-0750 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hokkaido University Hospital Sapporo, Japan, 060-8648 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Hospital Organization Osaka National Hospital Osaka, Japan, 540-0006 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kishiwada Tokushukai Hospital Kishiwada, Japan, 596-0042 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Hospital Organization Himeji Medical Center Himeji, Japan, 670-8520 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Osaka International Cancer Institute Osaka, Japan, 541-8567 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hiroshima City Hiroshima Citizens Hospital Hiroshima, Japan, 730-8518 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hyogo Prefectural Nishinomiya Hospital Nishinomiya, Japan, 662-0918 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MVZ Prof. Uhlenbrock und Partner Dortmund, Germany, 44263 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Northwestern University Chicago, United States, 60611 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Charité Campus Benjamin Franklin (CBF) Berlin, Germany, 12203 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universität Rostock - Medizinische Fakultät Rostock, Germany, 18057 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Multicenter, single-blind, adaptive dose finding study of single intravenous injections of BAY 1747846 with corresponding blinded read in adult participants with known or highly suspected CNS lesions referred for contrast-enhanced MRI of the CNS
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
N/A
Blinding:
N/A
Assignment:
Single Group Assignment
Trial Arms:
1
Not Available