Clinical trial · Interventional
Multihance Versus Magnevist in Breast MRI
Phase III Multicenter Double-Blind, Randomized, Crossover Study to Compare MultiHance With Magnevist in Contrast-enhanced Magnetic Resonance Imaging (MRI) of the Breast
NCT00486473CI-TRIAL-00003670DETECTcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To show if one MRI contrast agent is better than another one in the diagnosis of malignant breast lesions compared to histopathology
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnevist | Drug | — | UNRESOLVED |
| Multihance | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sensitivity in diagnosing breast lesions compared to histopathology results
- timeFrame
- up to 6 months
Secondary outcomes (1)
- measure
- Sensitivity, specificity, accuracy, PPV and NPV at region, breast and patient levels
- timeFrame
- up to 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMartincich 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 21163915