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Trial record 5 of 96 for:    gadobenate dimeglumine

Multihance at 3 Tesla in Brain Tumors

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ClinicalTrials.gov Identifier: NCT00395863
Recruitment Status : Completed
First Posted : November 6, 2006
Results First Posted : July 31, 2009
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

Tracking Information
First Submitted Date  ICMJE September 12, 2006
First Posted Date  ICMJE November 6, 2006
Results First Submitted Date  ICMJE March 30, 2009
Results First Posted Date  ICMJE July 31, 2009
Last Update Posted Date April 14, 2015
Study Start Date  ICMJE November 2006
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2010)
Global Diagnostic Preference Between the Two Exams [ Time Frame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2006)
Global preference between the two exams
Change History Complete list of historical versions of study NCT00395863 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2010)
  • Lesion Border Delineation [ Time Frame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2006)
Global preference for border delineation of lesions; conspicuity of lesions; lesion count; LBR for each lesion; CNR for each lesion and percent enhancement
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multihance at 3 Tesla in Brain Tumors
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Brain Tumor
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2008)
46
Original Enrollment  ICMJE
 (submitted: November 3, 2006)
35
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00395863
Other Study ID Numbers  ICMJE MH 126
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bracco Diagnostics, Inc
Study Sponsor  ICMJE Bracco Diagnostics, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gianpaolo Priovano, M.D. Bracco Diagnostics, Inc
PRS Account Bracco Diagnostics, Inc
Verification Date March 2015

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