Male and female patients of any ethnic group who are referred for a contrast-enhanced MRI of the CNS based on current clinical symptoms or results of a previous imaging procedure. MedDRA version: 9.1 Level: LLT Classification code 10061816 Term: Diagnostic procedure
Conditions
Interventions
Trade Name: Gadovist 1.0 mmol/ml, solution for injection
Product Name: Gadovist
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GADOBUTROL
CAS Number: 138071826
Current Sponsor code:
Sponsors
Bayer HealthCare Pharmaceuticals INC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient who meets the following criteria will be eligible for enrollment into the study: 1. Is at least 18 years of age 2. Is referred for a contrast-enhanced MRI of the CNS based on current clinical symptoms or results of a previous imaging procedure 3. Is willing to undergo the routine contrast-enhanced MRI examinations with gadoteridol and with gadobutrol 4. Is willing and able to complete all study procedures specified in the protocol 5. Patient is male, or is female not of childbearing potential, or is female of childbearing potential who is using any medically accepted means of contraception and has a negative urine pregnancy test within 1 hour prior to the administration of gadobutrol and gadoteridol 6. Has a glomerular filtration rate (GFR) value = 60 mL/min/1.73m2 derived from a serum creatinine result within 2 weeks prior to study enrollment 7. Has been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable, and has consented to participate 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A patient who meets any of the following criteria may not participate in this study: 1. Is a female patient who is pregnant or nursing 2. Has received any investigational product or has participated in any other clinical trial within 30 days prior to enrolling in this study 3. Has been previously enrolled in this study or any other study using gadobutrol 4. Has any contraindication to the MRI examinations or the use of Gd-containing contrast agents 5. Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents 6. Has received any contrast agent within 24 hours prior to the study MRIs, or is scheduled to receive any contrast agent within 72 hours after the second study MRI 7. Is considered clinically unstable or his/her clinical course during the study period is unpredictable (eg, due to previous surgery, acute renal failure) 8. Has severe cardiovascular disease (eg. known long QT syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours) 9. Patients with acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period 10. Has any contraindication to gadoteridol according to the package insert 11. Is expected or is scheduled to have a change in any treatment or procedure between the gadoteridol and gadobutrol MRIs that may alter their interpretation 12. Is scheduled or is likely to require a biopsy or any interventional therapeutic procedure from the first study MRI up to 72 hours after the second study MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Demonstrate noninferiority of gadobutrol compared to gadoteridol at a dose of 0.1 mmol/kg for: • Degree of contrast enhancement • Assessment of border delineation • Internal morphology of lesions • Total number of lesions detected Demonstrate improvement of gadobutrol-enhanced MRI to unenhanced MRI and noninferiority to gadoteridol-enhanced MRI for: • Exact match of the MR diagnoses with the final clinical diagnosis • Sensitivity and specificity for normal/abnormal brain tissue based on the comparison of the T1-weighted (T1w) contrast-enhanced and T1w unenhanced MR images • Sensitivity and specificity for the detection of malignant CNS lesions • Confidence in diagnosis Compare gadobutrol to gadoteridol for: • T1w MRI image quality in a paired comparison • The number of contrast-enhanced lesions • Quantitative parameters based on signal intensity (SI) measurements Assess the safety profile of gadobutrol compared to gadoteridol after intravenous (IV) administration.;Primary end point(s): The 4 primary efficacy variables will be lesion visualization parameters (see Section 8.2.2.1 for details): • Total number of lesions detected • Degree of contrast enhancement • Border delineation • Internal morphology Secondary efficacy variables The secondary efficacy variables will be the: • Exact match of the MR diagnoses with the final clinical diagnosis • Assessment of normal (specificity) and abnormal (sensitivity) brain tissue • Assessment of malignant CNS lesions • Confidence in diagnosis • SI measurements • Number of contrast-enhanced lesions ;Main Objective: Superiority of combined unenhanced and gadobutrol-enhanced magnetic resonance imaging (MRI) compared to unenhanced MRI based on the evaluation of the following: • Degree of contrast enhancement • Assessment of border delineation • Internal morphology of lesions And noninferiority of combined unenhanced and gadobutrol-enhanced magnetic resonance imaging (MRI) compared to unenhanced MR | — |
Countries
Austria, Germany
Outcome results
None listed