Multihance at 3 Tesla (3T) in Brain Tumors

Bracco

Status and phase: Completed; Phase 4

Conditions: Brain Tumor

Treatments: Drug: Multihance; Drug: Arm 2 - Magnevist

Study type: Interventional

Funder types: Industry

Identifiers

NCT00395863

MH 126

Details and patient eligibility

About

Compare the efficacy of MultiHance and Magnevist

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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46 participants in 2 patient groups

MultiHance

Active Comparator group

Description:

0.5 M MultiHance at a single injection

Treatment:

Drug: Multihance

Magnevist

Active Comparator group

Description:

0.5 M Magnevist at a single injection

Treatment:

Drug: Arm 2 - Magnevist