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Multihance at 3 Tesla (3T) in Brain Tumors

Primary Purpose

Brain Tumor

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Multihance
Arm 2 - Magnevist
Sponsored by
Bracco Diagnostics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bracco Diagnostics, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MultiHance

Magnevist

Arm Description

0.5 M MultiHance at a single injection

0.5 M Magnevist at a single injection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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)]
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)]
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)]

Full Information

First Posted
September 12, 2006
Last Updated
October 14, 2020
Sponsor
Bracco Diagnostics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00395863
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bracco Diagnostics, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MultiHance
Arm Type
Active Comparator
Arm Description
0.5 M MultiHance at a single injection
Arm Title
Magnevist
Arm Type
Active Comparator
Arm Description
0.5 M Magnevist at a single injection
Intervention Type
Drug
Intervention Name(s)
Multihance
Other Intervention Name(s)
gadobenate dimeglumine
Intervention Description
0.5 M at a single injection
Intervention Type
Drug
Intervention Name(s)
Arm 2 - Magnevist
Other Intervention Name(s)
gadopentetate dimeglumine
Intervention Description
0.5 M Magnevist at a single dose injection
Primary Outcome Measure Information:
Title
Global Diagnostic Preference Between the Two Exams
Description
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.
Time Frame
Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Secondary Outcome Measure Information:
Title
Lesion Border Delineation
Description
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.
Time Frame
Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Title
Lesion Contrast Enhancement Between the Two Exams
Description
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.
Time Frame
Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Title
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1
Description
Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Time Frame
Predose and immediately postdose
Title
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2
Description
Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Time Frame
Predose and immediately postdose
Title
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3
Description
Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Time Frame
Predose and immediately postdose
Title
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1
Description
Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Time Frame
Predose and immediately postdose
Title
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2
Description
Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Time Frame
Predose and immediately postdose
Title
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3
Description
Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Time Frame
Predose and immediately postdose
Title
Percentage of Lesion Contrast Enhancement (LCE) - Reader 1
Description
Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]
Time Frame
Postdose
Title
Percentage of Contrast Enhancement of the Lesion - Reader 2
Description
Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]
Time Frame
Postdose
Title
Percentage of Contrast Enhancement of the Lesion - Reader 3
Description
Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]
Time Frame
Postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianpaolo Priovano, M.D.
Organizational Affiliation
Bracco Diagnostics, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Bracco Diagnostics, Inc.
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19306364
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.
Results Reference
result

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Multihance at 3 Tesla (3T) in Brain Tumors

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