NCT00302120

The MONET - Study: MR Mammography of Nonpalpable Breast Tumors

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Contrast-enhanced MR mammography

Timeline

• Start date: 2006-02-01
• Primary completion: 2009-03-01
• Completion: 2010-03-01
• First posted: 2006-03-13
• Last updated: 2008-06-10

Locations

3 sites across 1 country: Netherlands