Trial Condition(s):

Central Nervous System Pathology

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

Bayer Identifier:

20241

ClinicalTrials.gov Identifier:

NCT04307186

EudraCT Number:

2019-001560-30

Study Completed

Trial Purpose

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.

Inclusion Criteria
- 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.
Exclusion Criteria
- Considered clinically unstable or has a concomitant/intercurrent condition (e.g. COVID-19 infection) that would not allow participation for the full planned study period (i.e. period 1, 2 or both) in the judgement of the investigator. 
- Severe cardiovascular disease. 
- Patients undergoing liver transplantation.
- Any contraindication to MRI examinations. 
- History of severe allergic or anaphylactic/anaphylactoid reaction to any allergen including drugs and contrast agents, foods, chemicals or other substances. 
- History of allergic asthma and/ or atopic dermatitis. 
- Suspected lesions or suffering from any of the following CNS diseases/lesion types as the main indication for MRI: 
-- Lepto-meningeal disease (e.g. leptomeningeal carcinomatosis). Dural lesions (e.g. meningiomas) fulfilling inclusion criteria #2 are not excluded
-- 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 in the region of interest 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, as specified in the local product label.

Trial Summary

Enrollment Goal
57
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
BAY1747846
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitätsklinikum Essen

Essen, Germany, 45147

Status
Completed
 
Locations

University of Iowa Hospitals & Clinics

Iowa City, United States, 52242-1089

Status
Completed
 
Locations

Hokkaido University Hospital

Sapporo, Japan, 060-8648

Status
Completed
 
Locations

National Hospital Organization Osaka National Hospital

Osaka, Japan, 540-0006

Status
Terminated
 
Locations

Kishiwada Tokushukai Hospital

Kishiwada, Japan, 596-0042

Status
Completed
 
Locations

National Hospital Organization Himeji Medical Center

Himeji, Japan, 670-8520

Status
Completed
 
Locations

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, Japan, 730-8518

Status
Completed
 
Locations

Hyogo Prefectural Nishinomiya Hospital

Nishinomiya, Japan, 662-0918

Status
Completed
 
Locations

MVZ Prof. Uhlenbrock und Partner

Dortmund, Germany, 44263

Status
Completed
 
Locations

Northwestern University

Chicago, United States, 60611

Status
Completed
 
Locations

Penn State Milton S. Hershey Medical Center

Hershey, United States, 17033-0850

Status
Completed
 
Locations

Friedrich-Schiller-Uni. Jena

Jena, Germany, 07740

Status
Completed
 
Locations

Fukuoka Wajiro Hospital

Fukuoka, Japan, 811-0213

Status
Completed
 
Locations

National Hospital Organization Kanmon Medical Center

Shimonoseki, Japan, 752-8510

Status
Completed
 
Locations

National Hospital Organization Kyushu Medical Center

Fukuoka, Japan, 810-8563

Status
Completed
 
Locations

UMHAT Sveti Georgi

Plovdiv, Bulgaria, 4002

Status
Completed
 
Locations

Acibadem City Clinic Multiprofile Hospital for Active Treatm

Sofia, Bulgaria, 1407

Status
Completed
 
Locations

University Multiprofile Hosp. for Active Treat. Sveti Ivan

Sofia, Bulgaria, 1431

Status
Completed
 

Trial Design