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Multihance Versus Magnevist in Breast MRI (DETECT)

This study has been completed.
Information provided by:
Bracco Diagnostics, Inc Identifier:
First received: June 13, 2007
Last updated: July 14, 2010
Last verified: July 2010
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

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
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Please refer to this study by its identifier: 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 Identifier (NCT Number):
Responsible Party: Gianpaolo Pirovano, M.D., Executive Director, Corporate Medical Development, Bracco Diagnostics, Inc. Identifier: NCT00486473     History of Changes
Other Study ID Numbers: MH 131
Study First Received: June 13, 2007
Last Updated: July 14, 2010 processed this record on August 18, 2017