Trial Information

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

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).