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Completed

NCT Number: NCT00395863

Multihance at 3 Tesla (3T) in Brain Tumors

Compare the efficacy of MultiHance and Magnevist

Completed

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Key information

Conditions

Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bracco Diagnostics, Inc.

Princeton, New Jersey, 08540, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multihance

Drug

0.5 M at a single injection

Other names: gadobenate dimeglumine

Arm 2 - Magnevist

Drug

0.5 M Magnevist at a single dose injection

Other names: gadopentetate dimeglumine

Primary outcomes

  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 preferred, both contrast agents were equal, or the image with Magnevist was preferred. Each patient's image was reviewed by 3 readers.

Secondary outcomes

  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 preferred, 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 preferred, 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 Lesion Contrast Enhancement (LCE) - 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)]

Sponsors and collaborators

Lead sponsor

Bracco Diagnostics, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 6, 2006
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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