The MONET - Study: MR Mammography of Nonpalpable Breast Tumors
Recruitment status was Recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Procedure: Contrast-enhanced MR mammography |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- The absolute number of surgical procedures in women with nonpalpable malignancies will be compared between MRI group and control group. [ Time Frame: 2010 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 440 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
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).
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders 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
Contacts and Locations| 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 |
More Information
No publications provided
| 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 |
| Study First Received: | March 10, 2006 |
| Last Updated: | June 9, 2008 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by UMC Utrecht:
|
Magnetic Resonance Imaging Breast Neoplasms Diagnostic Trial |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013