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

Phase 1

Conditions: MedDRA version: 22.1Level: LLTClassification code 10029820Term: Nuclear magnetic resonance imaging gadolinium-enhancedSystem Organ Class: 100000004848
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Central nervous system (CNS) pathology
MedDRA version: 20.0Level: PTClassification code 10051290Term: Central nervous system lesionSystem Organ Class: 10029205 - Nervous system disorders

Registration Number: EUCTR2019-001560-30-BG

Lead Sponsor: Bayer AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

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/1.73m2 at baseline. With regards to baseline of period 1, eGFR value can be derived from a serum creatinine result within 4 weeks prior to the first study MRI determined by local hospital lab.
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. 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. 6. History of allergic asthma. 7 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. 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 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. Has been previously enrolled in this study.
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 follow-up 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.
13. Contraindications to the administration of gadobutrol (depending on local product label).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To identify a dose for further development that has an overall diagnostic preference rate similar to that of the comparator gadobutrol at 5 min post injection;Secondary Objective: To show non-inferiority of BAY1747846 compared to gadobutrol at 5 min post injection with respect to sum of lesion visualization parameters;Primary end point(s): Overall diagnostic preference;Timepoint(s) of evaluation of this end point: At 5 minute post injection

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Sum of lesion visualization parameters<br> - Lesion visualization parameters (border delineation, contrast enhancement, internal<br>morphology) on pre-contrast and combined pre- and post-contrast (5 min pi) images;<br> - Number of lesions on pre-contrast and combined pre and post-contrast (5 min pi)<br>images;Timepoint(s) of evaluation of this end point: At 5 minute post injection

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