Phase 4 N=157 Diagnostic

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

Magnetic Resonance Imaging

Bottom Line

View on ClinicalTrials.gov: NCT03602339 ↗

Enrolled (actual)

157

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcome: Primary: Degree of Lesion Contrast Enhancement — 0.884; 0.863; 3.007; 2.979 Scores on a scale — p=< 0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Gadoterate (Dotarem/Clariscan) (Drug); Gadobutrol (Gadavist/Gadovist, BAY86-4875) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bayer
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Degree of Lesion Contrast Enhancement	0.884; 0.863; 3.007; 2.979	< 0.0001 sig
PRIMARY Lesion Border Delineation	2.279; 2.278; 3.096; 3.099	= 0.0151 sig
PRIMARY Lesion Internal Morphology	1.835; 1.823; 2.503; 2.484	= 0.0100 sig
SECONDARY Number of Lesions Identified	2.064; 2.137	—
SECONDARY Detection of Malignant Disease	70.2; 70.2; 58.7; 58.7; 91.8; 91.8	—
SECONDARY Confidence in Diagnosis	3.272; 3.348	—
SECONDARY Image Quality	0.00	0.9149
SECONDARY Contrast Enhancement Utilizing an Exploratory Overall Contrast Enhancement Estimation Algorithm	0.19894; 0.18564; 0.05604; 0.05573; 0.92984; 0.92991	—
SECONDARY Number of Participants With Treatment-emergent Adverse Events	4; 1; 2; 1; 0; 0	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03602339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.