Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
130 participants
INTERVENTIONAL
2007-07-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
TRIPLE
Interventions
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Multihance
0.5 Molar at a single dose injection
Magnevist
0.5M at a single dose injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Bracco Diagnostics, Inc
INDUSTRY
Responsible Party
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Bracco Diagnostics, Inc.
Principal Investigators
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Gianpaolo Pirovano, MD
Role: STUDY_DIRECTOR
Bracco Dianostics, Inc.
Locations
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Rome, , Italy
Countries
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References
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Martincich L, Faivre-Pierret M, Zechmann CM, Corcione S, van den Bosch HC, Peng WJ, Petrillo A, Siegmann KC, Heverhagen JT, Panizza P, Gehl HB, Diekmann F, Pediconi F, Ma L, Gilbert FJ, Sardanelli F, Belli P, Salvatore M, Kreitner KF, Weiss CM, Zuiani C. Multicenter, double-blind, randomized, intraindividual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine for Breast MR imaging (DETECT Trial). Radiology. 2011 Feb;258(2):396-408. doi: 10.1148/radiol.10100968. Epub 2010 Dec 16.
Other Identifiers
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MH 131
Identifier Type: -
Identifier Source: org_study_id
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