The MONET - Study: MR Mammography of Nonpalpable Breast Tumors (MONET)
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ClinicalTrials.gov Identifier: NCT00302120 |
Recruitment Status
: Unknown
Verified June 2008 by UMC Utrecht.
Recruitment status was: Recruiting
First Posted
: March 13, 2006
Last Update Posted
: June 10, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Neoplasms | Procedure: Contrast-enhanced MR mammography | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 440 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | 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 |
Study Start Date : | February 2006 |
Estimated Primary Completion Date : | March 2009 |
Estimated Study Completion Date : | March 2010 |

- The absolute number of surgical procedures in women with nonpalpable malignancies will be compared between MRI group and control group. [ Time Frame: 2010 ]
- The number of large core needle biopsies that can be prevented because of a definite diagnosis as provided by MRI will be calculated. [ Time Frame: 2009 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00302120
Contact: Nicky HG Peters, MD | 0031302503196 | n.peters@umcutrecht.nl | |
Contact: Petra HM Peeters, MD PhD | 0031302509363 | p.h.m.peeters@umcutrecht.nl |
Netherlands | |
Meander Medisch Centrum | Recruiting |
Amersfoort, Netherlands, 3818 ES | |
Albert Schweitzer Ziekenhuis | Recruiting |
Dordrecht, Netherlands, 3300 AK | |
Unicersity Medical Center Utrecht | Recruiting |
Utrecht, Netherlands, 3584 CX |
Study Director: | Willem P Mali, MD PhD | UMC Utrecht |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Porf. dr. W. Mali / Prof. dr. P. Peeters, University Medical Center Utrecht |
ClinicalTrials.gov Identifier: | NCT00302120 History of Changes |
Other Study ID Numbers: |
UMC Utrecht |
First Posted: | March 13, 2006 Key Record Dates |
Last Update Posted: | June 10, 2008 |
Last Verified: | June 2008 |
Keywords provided by UMC Utrecht:
Magnetic Resonance Imaging Breast Neoplasms Diagnostic Trial |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |