Multihance at 3 Tesla in Brain Tumors

This study has been completed.
Sponsor:
Information provided by:
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00395863
First received: September 12, 2006
Last updated: September 24, 2010
Last verified: September 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms
Gadobenic acid
Gadolinium DTPA
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2014