Phase 4 Completed N=46 Randomized Triple-blind Diagnostic

Multihance at 3 Tesla (3T) in Brain Tumors

Source: ClinicalTrials.gov NCT00395863 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2009

Primary outcomePrimary: Global Diagnostic Preference Between the Two Exams — 22; 21; 27; 19 Contrast-enhanced Images — p=< 0.0001

Summary

Compare the efficacy of MultiHance and Magnevist

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.