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Multihance Versus Magnevist in Breast MRI (DETECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00486473
Recruitment Status : Completed
First Posted : June 14, 2007
Last Update Posted : July 15, 2010
Information provided by:
Bracco Diagnostics, Inc

Brief Summary:
To show if one MRI contrast agent is better than another one in the diagnosis of malignant breast lesions compared to histopathology

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Multihance Drug: Magnevist Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Phase III Multicenter Double-Blind, Randomized, Crossover Study to Compare MultiHance With Magnevist in Contrast-enhanced Magnetic Resonance Imaging (MRI) of the Breast
Study Start Date : July 2007
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Multihance
    0.5 Molar at a single dose injection
    Drug: Magnevist
    0.5M at a single dose injection

Primary Outcome Measures :
  1. Sensitivity in diagnosing breast lesions compared to histopathology results [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. Sensitivity, specificity, accuracy, PPV and NPV at region, breast and patient levels [ Time Frame: up to 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Provides written informed consent
  • Female
  • Age 18 years or older
  • Suspicious or known breast lesion based on results from mammography or ultrasound
  • Planned to undergo histological diagnosis of breast lesion by having a non surgical biopsy or breast surgery within 30 days after the MRI exam

Exclusion Criteria:

  • Body weight > 100 kg
  • Pregnant or lactating
  • Server or end-stage organ failure
  • Moderate to severe renal impairment
  • Undergoing radiotherapy or completed radiotherapy in the last 18 months
  • Chemotherapy within 6 months of the 1st MRI exam

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): NCT00486473

Rome, Italy
Sponsors and Collaborators
Bracco Diagnostics, Inc
Study Director: Gianpaolo Pirovano, MD Bracco Dianostics, Inc.