Clinical trial NCT00395863: Multihance at 3 Tesla (3T) in Brain Tumors
Official title: A Phase IV Double-blind Multicenter Randomized Crossover Study to Compare 0.10 mmol/kg of Multihance With 0.10 mmol.kg of Magnevist in Magnetic Resonance Imaging(MRI) of the Brain at 3T
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Tumor
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2006-11-06
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Compare the efficacy of MultiHance and Magnevist

Detailed description: The purpose of this study was to evaluate whether Multihance is superior to Magnevist in terms of qualitative and quantitative assessment of unenhanced MRI and contrast-enhanced MRI for the visualization of brain disease.

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

Primary outcomes:
measure: Global Diagnostic Preference Between the Two Exams
timeFrame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Secondary outcomes:
measure: Lesion Border Delineation
timeFrame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared
measure: Lesion Contrast Enhancement Between the Two Exams
timeFrame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared
measure: Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1
timeFrame: Predose and immediately postdose
measure: Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2
timeFrame: Predose and immediately postdose
measure: Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3
timeFrame: Predose and immediately postdose
measure: Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1
timeFrame: Predose and immediately postdose
measure: Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2
timeFrame: Predose and immediately postdose
measure: Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3
timeFrame: Predose and immediately postdose
measure: Percentage of Lesion Contrast Enhancement (LCE) - Reader 1
timeFrame: Postdose
measure: Percentage of Contrast Enhancement of the Lesion - Reader 2
timeFrame: Postdose
measure: Percentage of Contrast Enhancement of the Lesion - Reader 3
timeFrame: Postdose
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bracco Diagnostics, Inc.
state: New Jersey
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Gianpaolo Priovano, M.D.
role: STUDY_DIRECTOR
References:
citation: Rumboldt Z, Rowley HA, Steinberg F, Maldjian JA, Ruscalleda J, Gustafsson L, Bastianello S. Multicenter, double-blind, randomized, intra-individual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine in MRI of brain tumors at 3 tesla. J Magn Reson Imaging. 2009 Apr;29(4):760-7. doi: 10.1002/jmri.21695.