The MONET - Study: MR Mammography of Nonpalpable Breast Tumors (MONET)

June 9, 2008 updated by: UMC Utrecht

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 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.

Study Overview

Status

Unknown

Conditions

Breast Neoplasms

Intervention / Treatment

Procedure: Contrast-enhanced MR mammography

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 Type

Interventional

Enrollment (Anticipated)

440

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Netherlands
- - Amersfoort, Netherlands, 3818 ES
    - Recruiting
    - Meander Medisch Centrum
  - Dordrecht, Netherlands, 3300 AK
    - Recruiting
    - Albert Schweitzer ziekenhuis
  - Utrecht, Netherlands, 3584 CX
    - Recruiting
    - Unicersity Medical Center Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The absolute number of surgical procedures in women with nonpalpable malignancies will be compared between MRI group and control group. Time Frame: 2010	2010

Secondary Outcome Measures

Outcome Measure	Time Frame
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	2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Investigators

Study Director: Willem P Mali, MD PhD, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Peters NH, Borel Rinkes IH, Mali WP, van den Bosch MA, Storm RK, Plaisier PW, de Boer E, van Overbeeke AJ, Peeters PH. Breast MRI in nonpalpable breast lesions: a randomized trial with diagnostic and therapeutic outcome - MONET - study. Trials. 2007 Nov 28;8:40. doi: 10.1186/1745-6215-8-40.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Anticipated)

March 1, 2009

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

March 10, 2006

First Submitted That Met QC Criteria