Phase 4
N=46
Multihance at 3 Tesla (3T) in Brain Tumors
Brain Tumor
Bottom Line
View on ClinicalTrials.gov: NCT00395863 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jul 2009
Primary outcome: Primary: Global Diagnostic Preference Between the Two Exams — 22; 21; 27; 19 Contrast-enhanced Images — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Multihance (Drug); Arm 2 - Magnevist (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bracco Diagnostics, Inc
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Diagnostic Preference Between the Two Exams |
22; 21; 27; 19; 19; 14 | < 0.0001 sig |
| SECONDARY Lesion Border Delineation |
14; 11; 13; 27; 30; 28 | 0.0001 sig |
| SECONDARY Lesion Contrast Enhancement Between the Two Exams |
22; 20; 22; 19; 20; 18 | <0.0001 sig |
| SECONDARY Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1 |
0.82; 0.85; 1.50; 1.31; 0.68; 0.46 | <0.0001 sig |
| SECONDARY Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2 |
0.82; 0.87; 1.61; 1.36; 0.79; 0.49 | <0.0001 sig |
| SECONDARY Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3 |
0.86; 0.91; 1.67; 1.46; 0.81; 0.55 | <0.0001 sig |
| SECONDARY Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1 |
-18.81; -11.70; 60.76; 26.87; 79.56; 38.57 | 0.0062 sig |
| SECONDARY Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2 |
-18.30; -14.38; 65.96; 38.94; 84.26; 53.31 | 0.0027 sig |
| SECONDARY Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3 |
-11.75; -6.47; 62.10; 42.34; 73.84; 48.81 | 0.02 sig |
| SECONDARY Percentage of Lesion Contrast Enhancement (LCE) - Reader 1 |
100.15; 67.38 | 0.0019 sig |
| SECONDARY Percentage of Contrast Enhancement of the Lesion - Reader 2 |
106.42; 72.81 | 0.0008 sig |
| SECONDARY Percentage of Contrast Enhancement of the Lesion - Reader 3 |
101.85; 68.13 | 0.0026 sig |
Summary
Compare the efficacy of MultiHance and Magnevist
Eligibility Criteria
Inclusion Criteria
- Was 18 years or older
- Provided written informed consent
- Scheduled for MRI
- Confirmed or highly suspected to have brain tumor(s) and willing to undergo two MRI exams within 14 days
Exclusion Criteria
- Pregnant or lactating females
- Allergy to one or more of the ingredients in the products or hypersensitivity to any metals
- Congestive heart failure, class IV
- Previous stroke in the past year
- Received another contrast agent within 24 hours pre and post each exam
- Investigational product
- Contraindications to MRI
- Severe claustrophobia
- Surgery with 3 weeks prior
- Steroid therapy or radiosurgery between two exams
Data sourced from ClinicalTrials.gov (NCT00395863). 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.