Multihance at 3 Tesla (3T) in Brain Tumors

NCT ID: NCT00395863

Last Updated: 2020-11-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-03-31

Brief Summary

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Compare the efficacy of MultiHance and Magnevist

Detailed Description

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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.

Conditions

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Brain Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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MultiHance

0.5 M MultiHance at a single injection

Group Type ACTIVE_COMPARATOR

Multihance

Intervention Type DRUG

0.5 M at a single injection

Magnevist

0.5 M Magnevist at a single injection

Group Type ACTIVE_COMPARATOR

Arm 2 - Magnevist

Intervention Type DRUG

0.5 M Magnevist at a single dose injection

Interventions

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Multihance

0.5 M at a single injection

Intervention Type DRUG

Arm 2 - Magnevist

0.5 M Magnevist at a single dose injection

Intervention Type DRUG

Other Intervention Names

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gadobenate dimeglumine gadopentetate dimeglumine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gianpaolo Priovano, M.D.

Role: STUDY_DIRECTOR

Bracco Diagnostics, Inc

Locations

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Bracco Diagnostics, Inc.

Princeton, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 19306364 (View on PubMed)

Other Identifiers

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MH 126

Identifier Type: -

Identifier Source: org_study_id