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Multihance Versus Magnevist in Breast MRI (DETECT)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 14, 2007
Last Update Posted: July 15, 2010
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.
Information provided by:
Bracco Diagnostics, Inc
To show if one MRI contrast agent is better than another one in the diagnosis of malignant breast lesions compared to histopathology

Condition Intervention Phase
Breast Cancer Drug: Multihance Drug: Magnevist Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Bracco Diagnostics, Inc:

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

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

Estimated Enrollment: 130
Study Start Date: July 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Multihance
    0.5 Molar at a single dose injection
    Drug: Magnevist
    0.5M at a single dose injection

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
  Contacts and Locations
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.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gianpaolo Pirovano, M.D., Executive Director, Corporate Medical Development, Bracco Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT00486473     History of Changes
Other Study ID Numbers: MH 131
First Submitted: June 13, 2007
First Posted: June 14, 2007
Last Update Posted: July 15, 2010
Last Verified: July 2010