The MONET - Study: MR Mammography of Nonpalpable Breast Tumors

Phase 4

• Conditions: Breast Neoplasms

• Registration Number: NCT00302120
• Lead Sponsor: UMC Utrecht

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.

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).

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-03-10
• Study First Submitted QC: 2006-03-10
• Study First Posted: 2006-03-13
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-09
• Last Update Posted: 2008-06-10
• Primary Completion: 2009-03
• Study Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 440

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The absolute number of surgical procedures in women with nonpalpable malignancies will be compared between MRI group and control group.	2010

Secondary Outcome Measures

Name	Time	Method
The number of large core needle biopsies that can be prevented because of a definite diagnosis as provided by MRI will be calculated.	2009

Trial Locations

Locations (3)

Meander Medisch Centrum; 🇳🇱 Amersfoort, Netherlands

Unicersity Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands

Albert Schweitzer Ziekenhuis; 🇳🇱 Dordrecht, Netherlands