Multihance at 3 Tesla (3T) in Brain Tumors

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

Compare the efficacy of MultiHance and Magnevist

Study Overview

• Status: Completed
• Conditions: Brain Tumor
• Intervention / Treatment: Drug: Multihance; Drug: Arm 2 - 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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MultiHance; 0.5 M MultiHance at a single injection	Drug: Multihance; 0.5 M at a single injection; Other Names: 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 Names: gadopentetate dimeglumine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Diagnostic Preference Between the Two Exams	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 preferred, both contrast agents were equal, or the image with Magnevist was preferred. Each patient's image was reviewed by 3 readers.	Postdose Images for MultiHance Exam and for Magnevist Exam Compared

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion Border Delineation	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 preferred, both contrast agents were equal, or the image with Magnevist was preferred.	Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Lesion Contrast Enhancement Between the Two Exams	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 preferred, both contrast agents were equal, or the image with Magnevist was preferred.	Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1	Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.	Predose and immediately postdose
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2	Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.	Predose and immediately postdose
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3	Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.	Predose and immediately postdose
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1	Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.	Predose and immediately postdose
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2	Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.	Predose and immediately postdose
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3	Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.	Predose and immediately postdose
Percentage of Lesion Contrast Enhancement (LCE) - Reader 1	Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]	Postdose
Percentage of Contrast Enhancement of the Lesion - Reader 2	Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]	Postdose
Percentage of Contrast Enhancement of the Lesion - Reader 3	Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]	Postdose

Collaborators and Investigators

• Sponsor: Bracco Diagnostics, Inc
• Investigators: Study Director: Gianpaolo Priovano, M.D., Bracco Diagnostics, Inc

Publications and helpful links

General 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. doi: 10.1002/jmri.21695.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: September 12, 2006
• First Submitted That Met QC Criteria: November 3, 2006
• First Posted (Estimate): November 6, 2006

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: MH 126