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

September 12, 2006
September 24, 2010
November 2006
February 2008   (final data collection date for primary outcome measure)
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.
Global preference between the two exams
Complete list of historical versions of study NCT00395863 on ClinicalTrials.gov Archive Site
  • 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)]
Global preference for border delineation of lesions; conspicuity of lesions; lesion count; LBR for each lesion; CNR for each lesion and percent enhancement
Not Provided
Not Provided
 
Multihance at 3 Tesla 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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Brain Tumor
  • Drug: Multihance
    0.5 M at a single injection
    Other Name: gadobenate dimeglumine
  • Drug: Arm 2 - Magnevist
    0.5 M Magnevist at a single dose injection
    Other Name: gadopentetate dimeglumine
  • Active Comparator: MultiHance
    0.5 M MultiHance at a single injection
    Intervention: Drug: Multihance
  • Active Comparator: Magnevist
    0.5 M Magnevist at a single injection
    Intervention: Drug: Arm 2 - Magnevist
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
March 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00395863
MH 126
No
Gianpaolo Pirovano, MD, Executive Director, Corporate Medical Development, Bracco Dianostics, Inc
Bracco Diagnostics, Inc
Not Provided
Study Director: Gianpaolo Priovano, M.D. Bracco Diagnostics, Inc
Bracco Diagnostics, Inc
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP