Skip to content

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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00302120
Acronym
MONET
Enrollment
440
Registered
2006-03-13
Start date
2006-02-28
Completion date
2010-03-31
Last updated
2008-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Magnetic Resonance Imaging, Breast Neoplasms, Diagnostic Trial

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).

Interventions

PROCEDUREContrast-enhanced MR mammography

Sponsors

UMC Utrecht
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Contacts

Primary ContactNicky HG Peters, MD
n.peters@umcutrecht.nl0031302503196
Backup ContactPetra HM Peeters, MD PhD
p.h.m.peeters@umcutrecht.nl0031302509363

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026