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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

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.

Condition or disease Intervention/treatment Phase
Brain Tumor Drug: Multihance Drug: Arm 2 - Magnevist Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
Study Start Date : November 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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)]

  10. 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)]

  11. 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)]



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT00395863     History of Changes
Other Study ID Numbers: MH 126
First Posted: November 6, 2006    Key Record Dates
Results First Posted: July 31, 2009
Last Update Posted: April 14, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases