Phase 4
Completed N=157
Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose
Magnetic Resonance Imaging
Source: ClinicalTrials.gov NCT03602339 ↗
Enrolled (actual)
157
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Degree of Lesion Contrast Enhancement — 0.884; 0.863; 3.007; 2.979 Scores on a scale — p=< 0.0001
◆ Published Evidence
Established
20citations · ~4 / year
Clinical Efficacy of Reduced-Dose Gadobutrol Versus Standard-Dose Gadoterate for Contrast-Enhanced MRI of the CNS: An International Multicenter Prospective Crossover Trial (LEADER-75).
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.
Linked Publications
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Clinical Efficacy of Reduced-Dose Gadobutrol Versus Standard-Dose Gadoterate for Contrast-Enhanced MRI of the CNS: An International Multicenter Prospective Crossover Trial (LEADER-75).
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT03602339) and the linked publication. 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. Informational only — not medical advice.