Clinical trial · Interventional
The MONET - Study: MR Mammography of Nonpalpable Breast Tumors
MR Mammography: Randomized Controlled Trial to Study Efficiency of MR Mammography in Reducing the Number of Invasive Interventions in Nonpalpable Suspicious Breast Lesions. The MONET - Study
NCT00302120CI-TRIAL-00001527MONETunknownPhase 4ClinicalTrials.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)
The purpose of this study is to determine whether performing MRI of the breast will improve breast cancer management by reducing the number of biopsies and in case of malignancy allowing one-stage surgical excision of the tumor.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast-enhanced MR mammography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The absolute number of surgical procedures in women with nonpalpable malignancies will be compared between MRI group and control group.
- timeFrame
- 2010
Secondary outcomes (1)
- measure
- The number of large core needle biopsies that can be prevented because of a definite diagnosis as provided by MRI will be calculated.
- timeFrame
- 2009
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * patients with a nonpalpable, mammographically suspicious breast lesion (BI-RADS 3, 4 or 5) * referred for large core needle biopsy * 18 to 75 years Exclusion Criteria: * previous breast surgery or radiation therapy of the breast less than 9 months before MR mammography * pregnant or lactating * claustrophobia or adiposity ( \> 130 kg) * general contraindications for MRI * unable to maintain prone position for one hour * medically unstable patients
References
Publications (1)
- DERIVEDPeters NH, Borel Rinkes IH, Mali WP, van den Bosch MA, Storm RK, Plaisier PW, de Boer E, van Overbeeke AJ, Peeters PH. Breast MRI in nonpalpable breast lesions: a randomized trial with diagnostic and therapeutic outcome - MONET - study. Trials. 2007 Nov 28;8:40. doi: 10.1186/1745-6215-8-40. PMID 18045470