The MONET - Study: MR Mammography of Nonpalpable Breast Tumors
Conditions
Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Magnetic Resonance Imaging, Breast Neoplasms, Diagnostic Trial
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: Contrast-enhanced MR mammography
Type: Procedure
Overall Status
Recruiting
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.
Detailed Description
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Female
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
Locations
Meander Medisch Centrum
Amersfoort, Netherlands
Status: Recruiting
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Status: Recruiting
Unicersity Medical Center Utrecht
Utrecht, Netherlands
Status: Recruiting
Start Date
February 2006
Completion Date
March 2010
Sponsors
UMC Utrecht
Source
UMC Utrecht
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page