Phase 3
N=343
Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging
Central Nervous System Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00623467 ↗Enrolled (actual)
343
Serious AEs
0.3%
Results posted
Oct 2011
Primary outcome: Primary: Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1) — 0.94; 2.96; 2.17; 3.01 scores on a scale — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Gadobutrol (Gadavist, Gadovist, BAY86-4875) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1) |
0.94; 2.96; 2.17; 3.01; 1.87; 2.40 | < 0.0001 sig |
| PRIMARY Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2) |
0.93; 2.87; 1.98; 3.15; 1.38; 2.46 | < 0.0001 sig |
| PRIMARY Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 3 (BR3) |
0.93; 2.86; 1.64; 2.76; 1.49; 2.25 | <0.0001 sig |
| PRIMARY Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR) |
0.93; 2.86; 1.92; 2.94; 1.57; 2.35 | < 0.0001 sig |
| PRIMARY Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers |
2.26; 2.93; 3.77; 3.60; 1.92; 2.37 | — |
| SECONDARY Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator |
NA; 2.97; 2.51; 3.40; 2.03; 2.78 | < 0.0001 sig |
| SECONDARY Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator |
2.53; 2.74 | — |
| SECONDARY Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1) |
0.84; 2.42; 1.66; 2.40; 1.66; 2.11 | < 0.0001 sig |
| SECONDARY Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2) |
0.80; 2.28; 1.67; 2.79; 1.19; 2.22 | < 0.0001 sig |
| SECONDARY Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3) |
0.81; 2.48; 1.07; 2.34; 1.10; 2.00 | < 0.0001 sig |
| SECONDARY Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR) |
0.79; 2.29; 1.42; 2.42; 1.27; 2.04 | < 0.0001 sig |
| SECONDARY Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1) |
1.00; 3.40; 2.57; 3.51; 2.03; 2.65 | < 0.0001 sig |
| SECONDARY Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2) |
1.01; 3.36; 2.18; 3.45; 1.49; 2.67 | < 0.0001 sig |
| SECONDARY Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3) |
1.00; 3.22; 2.07; 3.15; 1.79; 2.50 | < 0.0001 sig |
| SECONDARY Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR) |
1.01; 3.33; 2.28; 3.37; 1.77; 2.61 | < 0.0001 sig |
| SECONDARY Scores for Contrast Enhancement for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI by Clinical Investigator |
2.84 | — |
| SECONDARY Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator |
2.44; 3.26; 2.06; 2.73 | < 0.0001 sig |
| SECONDARY Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator |
NA; 3.47; 2.56; 3.55; 1.97; 2.82 | < 0.0001 sig |
| SECONDARY Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader |
51.8; 61.2 | 0.0002 sig |
| SECONDARY Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator |
67.0; 74.3 | 0.0001 sig |
| SECONDARY Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images |
74.9; 79.9 | 0.0285 sig |
| SECONDARY Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images |
75.4; 83.9 | 0.0004 sig |
| SECONDARY Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images |
72.5; 60.0 | 0.0588 |
| SECONDARY Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader |
82.4; 87.4 | 0.0093 sig |
| SECONDARY Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader |
57.1; 77.8 | 0.0003 sig |
| SECONDARY Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader |
90.4; 90.4 | 1.0000 |
| SECONDARY Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator |
88.9; 92.7 | 0.0016 sig |
| SECONDARY Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator |
71.4; 79.4 | 0.0253 sig |
| SECONDARY Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator |
94.4; 97.0 | 0.0253 sig |
| SECONDARY Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader |
2.70; 3.13 | < 0.0001 sig |
| SECONDARY Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator |
2.61; 3.45 | < 0.0001 sig |
Summary
This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadavist. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Gadavist.
Eligibility Criteria
Inclusion Criteria
- Patients referred for contrast enhanced MRI of the CNS based on symptoms or previous procedures.
Exclusion Criteria
- Patients with acute renal insufficiency
- Patients with severe renal disease
- Patients with any contraindication to magnetic resonance imaging.
Data sourced from ClinicalTrials.gov (NCT00623467). 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.