Status:
COMPLETED
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
Lead Sponsor:
Bayer
Conditions:
Central Nervous System Pathology
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2022
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04307186
Start Date
November 18 2020
End Date
September 6 2022
Last Update
November 15 2023
Active Locations (17)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242-1089
3
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
4
UMHAT Sveti Georgi
Plovdiv, Bulgaria, 4002