Phase 3
Completed N=147
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients
Central Nervous System Diseases
Source: ClinicalTrials.gov NCT00395460 ↗
Enrolled (actual)
147
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcomePrimary: Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions — 50.41; 43.47 Contrast to Noise ratio
Summary
The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions |
50.41; 43.47 | — |
| SECONDARY Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan |
0.7; 0.1; 1.4; 0.3; 1.7; 0.3 | — |
| SECONDARY Change in Diagnostic Confidence From Pre- to Post-contrast Magnetic Resonance Imaging by Treatment |
68; 65; 2; 10; 0; 0 | — |
| SECONDARY Change in Lesion Contrast Enhancement From Pre- to Post-contrast MRI |
2.4; 2.2; 2.1; 2.0; 1.7; 1.6 | — |
| SECONDARY Change in Lesion Delineation Between Pre- and Post-contrast MRI Scan of CNS Lesions |
1.1; 1.0; 1.4; 1.3; 0.9; 0.8 | — |
Eligibility Criteria
Inclusion Criteria
- Chinese origin, with known or suspected brain or spine diseases
Exclusion Criteria
- Pregnancy
- Lactation
- Conditions interfering with MRI
- Allergy to any contrast agent or any drugs
- Participation in other trial
- Require emergency treatment
- Severely impaired liver and kidney functions
Data sourced from ClinicalTrials.gov (NCT00395460). 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.