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

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 57

Inclusion Criteria

1. Participant must be at least 18 years of age at the time of signing the informed consent. 2. Known or highly suspected CNS pathology (contrast-enhancing CNS lesion) referred for contrast-enhanced MRI of the CNS. 3. Male and female. 4. Estimated glomerular filtration rate (eGFR) value =60 mL/min/1.73m^2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. 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 in the judgement of the investigator. 2. Severe cardiovascular disease. 3. Patients undergoing liver transplantation. 4. Any contraindication to MRI examinations. 5. History of severe allergic or anaphylactic/anaphylactoid reaction to any allergen including drugs and contrast agents, foods, chemicals or other substances. 6. History of allergic asthma and/ or atopic dermatitis. 7. 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. 8. 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. 9. 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. 10. 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. 11. Contraindications to the administration of gadobutrol, i.e. history of severe hypersensitivity reaction to gadobutrol (depending on local product label). 12. Has
received any investigational product within 30 days, or within 5 times
half-life of the investigational product, whichever is shorter, prior to
enrolling in this study. Note: Participants who have entered the followup period of or have been discontinued from an investigational study may participate as long as it has been 30 days after the last dose of the previous investigational product, or 5 times half-life of that investigational product, whichever is shorter.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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