Multihance at 3 Tesla in Brain Tumors - Full Text View

Purpose

The purpose of this study is 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.

Condition	Intervention	Phase
Brain Tumor	Drug: Multihance Drug: Arm 2 - Magnevist	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic
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

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer

Drug Information available for: Gadopentetate dimeglumine Gadobenate Dimeglumine

U.S. FDA Resources

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:

Global Diagnostic Preference Between the Two Exams [ Time Frame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared ] [ Designated as safety issue: No ]
Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.

Secondary Outcome Measures:

Lesion Border Delineation [ Time Frame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared ] [ Designated as safety issue: No ]
Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.
Lesion Contrast Enhancement Between the Two Exams [ Time Frame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared ] [ Designated as safety issue: No ]
Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1 [ Time Frame: Predose and immediately postdose ] [ Designated as safety issue: No ]
Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2 [ Time Frame: Predose and immediately postdose ] [ Designated as safety issue: No ]
Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3 [ Time Frame: Predose and immediately postdose ] [ Designated as safety issue: No ]
Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1 [ Time Frame: Predose and immediately postdose ] [ Designated as safety issue: No ]
Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2 [ Time Frame: Predose and immediately postdose ] [ Designated as safety issue: No ]
Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3 [ Time Frame: Predose and immediately postdose ] [ Designated as safety issue: No ]
Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Percentage of Contrast Enhancement of the Lesion - Reader 1 [ Time Frame: Postdose ] [ Designated as safety issue: No ]
Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]
Percentage of Contrast Enhancement of the Lesion - Reader 2 [ Time Frame: Postdose ] [ Designated as safety issue: No ]
Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]
Percentage of Contrast Enhancement of the Lesion - Reader 3 [ Time Frame: Postdose ] [ Designated as safety issue: No ]
Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]

Enrollment:	46
Study Start Date:	November 2006
Study Completion Date:	March 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: MultiHance 0.5 M MultiHance at a single injection	Drug: Multihance 0.5 M at a single injection Other Name: gadobenate dimeglumine
Active Comparator: Magnevist 0.5 M Magnevist at a single injection	Drug: Arm 2 - Magnevist 0.5 M Magnevist at a single dose injection Other Name: gadopentetate dimeglumine

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years or older
Provide 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395863

Locations

United States, New Jersey
Bracco Diagnostics, Inc.
Princeton, New Jersey, United States, 08540

Sponsors and Collaborators

Bracco Diagnostics, Inc

Investigators

Study Director:

Gianpaolo Priovano, M.D.

Bracco Diagnostics, Inc

More Information

Publications:

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.

Responsible Party:	Gianpaolo Pirovano, MD, Executive Director, Corporate Medical Development, Bracco Dianostics, Inc
ClinicalTrials.gov Identifier:	NCT00395863 History of Changes
Other Study ID Numbers:	MH 126
Study First Received:	September 12, 2006
Results First Received:	March 30, 2009
Last Updated:	September 24, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site

Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013