The MONET - Study: MR Mammography of Nonpalpable Breast Tumors (MONET)
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| ClinicalTrials.gov Identifier: NCT00302120 |
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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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Sponsor:
UMC Utrecht
Information provided by:
UMC Utrecht
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Neoplasms | Procedure: Contrast-enhanced MR mammography | Phase 4 |
Each year 7000 women present with nonpalpable suspicious breast lesions on mammography in the Netherlands. In the usual care situation, these lesions are detected by mammography and ultrasonography and pathologically characterized by analysis of large core needle biopsy material. In case of malignancy, these lesions are surgically removed. First, a wire is placed in the breast with the tip of the wire within 1 cm of the tumor and then the surgeon follows the wire and removes the lesion. Unfortunately about 25% of women require more that one surgical procedure to remove all tumorous tissue. This is caused by incorrect presurgical diagnosis of the extent and invasiveness of the disease (multifocality, multicentricity, lymph node involvement). We hypothesize that MR mammography will improve presurgical diagnosis and differentiation of lesions and thereby decrease the number of invasive surgical procedures (primary outcome) and number of invasive biopsies (secondary outcome).
| 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Breast cancer
Primary Outcome Measures :
- The absolute number of surgical procedures in women with nonpalpable malignancies will be compared between MRI group and control group. [ Time Frame: 2010 ]
Secondary Outcome Measures :
- 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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
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
Contacts
| Contact: Nicky HG Peters, MD | 0031302503196 | n.peters@umcutrecht.nl | |
| Contact: Petra HM Peeters, MD PhD | 0031302509363 | p.h.m.peeters@umcutrecht.nl |
Locations
| 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 | |
Sponsors and Collaborators
UMC Utrecht
Investigators
| 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:
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Magnetic Resonance Imaging Breast Neoplasms Diagnostic Trial |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |