The MONET - Study: MR Mammography of Nonpalpable Breast Tumors
MONET
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
1 other identifier
interventional
440
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2006
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 10, 2006
CompletedFirst Posted
Study publicly available on registry
March 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedJune 10, 2008
June 1, 2008
3.1 years
March 10, 2006
June 9, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The absolute number of surgical procedures in women with nonpalpable malignancies will be compared between MRI group and control group.
2010
Secondary Outcomes (1)
The number of large core needle biopsies that can be prevented because of a definite diagnosis as provided by MRI will be calculated.
2009
Interventions
Eligibility Criteria
You may qualify if:
- patients with a nonpalpable, mammographically suspicious breast lesion (BI-RADS 3, 4 or 5)
- referred for large core needle biopsy
- to 75 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
Study Sites (3)
Meander Medisch Centrum
Amersfoort, 3818 ES, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, 3300 AK, Netherlands
Unicersity Medical Center Utrecht
Utrecht, 3584 CX, Netherlands
Related Publications (1)
Peters 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: 18045470DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Willem P Mali, MD PhD
UMC Utrecht
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 10, 2006
First Posted
March 13, 2006
Study Start
February 1, 2006
Primary Completion
March 1, 2009
Study Completion
March 1, 2010
Last Updated
June 10, 2008
Record last verified: 2008-06