A study to look at whether a lower dose of study drug Gadovist is effective compared to Dotarem

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

1. Have known or highly suspected CNS pathology referred for contrast-enhanced MRI of the CNS based on current clinical symptoms or on a previous procedure.

2. If female and of child bearing potential, have a negative urine pregnancy test within 1 hour prior to the administration of gadoterate (the first MRI).

3. Have an estimated glomerular filtration rate (eGFR) value = 60 mL/min/1.73m2 derived from a serum creatinine result within four (4) weeks prior to the first study MRI.

4. Be fully informed about the study, including provisions of the Health Insurance Portability
and Accountability Act (HIPAA) as applicable, and consent 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 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

1. Has no enhancing lesion visible on the gadoterate-enhanced MRI scan.

2. Is pregnant or breast feeding

3. Has received any investigational product or has participated in any other clinical trial within 30 days prior to enrolling in this study

4. Has any contraindication to the MRI examinations or the use of gadolinium containing contrast agents

5. Has a history of severe allergic or anaphylactic/anaphylactoid reaction to any allergen including drugs and contrast agents

6. Has received any gadolinium-based contrast agent < 24 hours prior to the study MRIs, or is scheduled to receive any contrast agent within 24 hours after the second study MRI

7. Is considered clinically unstable

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. Is expected or is scheduled to have a change in any treatment or procedure between the gadoterate and gadobutrol MRIs that may alter image comparability

10. Is scheduled or is likely to require a biopsy or any interventional therapeutic procedure from the first study MRI up to 24 hours after the second study MRI

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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