Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose

• Status: Completed
• Trial end date: 2020-05-26
• Target enrollment: 0
• Participant gender: All

Summary

The study was conducted to gain knowledge about a new dose of a diagnostic drug that is used for contrast-enhanced Magnetic Resonance Imaging (MRI) of the human central nervous system (CNS). MRI can visualize the anatomy of the body and is used to detect medical conditions. Diagnostic drugs like gadobutrol and gadoterate contain an element called gadolinium that is applied to improve the analysability of MRI-images.

The purpose of this study was to examine if contrast-enhanced MRI using a reduced dose of the gadolinium-based contrast agent gadobutrol delivers images of similar quality to those obtained when a full dose of the gadolinium-based contrast agent gadoterate was used.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate

Criteria

Inclusion Criteria:

• Known or highly suspected central nervous system (CNS) pathology referred for contrast-enhanced MRI of the CNS.

• Glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m2 derived from a serum creatinine result within four weeks prior to the first study MRI.

• Women with negative urine pregnancy test within 1 hour prior to the administration of gadoterate (the first MRI).

Exclusion Criteria:

• No enhancing lesion visible on the gadoterate-enhanced MRI scan.

• Pregnancy or breastfeeding.

• Severe cardiovascular disease