Multihance Versus Magnevist in Breast MRI
DETECT
Phase III Multicenter Double-Blind, Randomized, Crossover Study to Compare MultiHance With Magnevist in Contrast-enhanced Magnetic Resonance Imaging (MRI) of the Breast
1 other identifier
interventional
130
1 country
1
Brief Summary
To show if one MRI contrast agent is better than another one in the diagnosis of malignant breast lesions compared to histopathology
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 breast-cancer
Started Jul 2007
Shorter than P25 for phase_3 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2007
CompletedFirst Posted
Study publicly available on registry
June 14, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJuly 15, 2010
July 1, 2010
2.4 years
June 13, 2007
July 14, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity in diagnosing breast lesions compared to histopathology results
up to 6 months
Secondary Outcomes (1)
Sensitivity, specificity, accuracy, PPV and NPV at region, breast and patient levels
up to 6 months
Interventions
0.5 Molar at a single dose injection
0.5M at a single dose injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Rome, Italy
Related Publications (1)
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.
PMID: 21163915DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gianpaolo Pirovano, MD
Bracco Dianostics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 13, 2007
First Posted
June 14, 2007
Study Start
July 1, 2007
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
July 15, 2010
Record last verified: 2010-07