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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Breast Neoplasms	Procedure: Contrast-enhanced MR mammography	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	440 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	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
Study Start Date :	February 2006
Estimated Primary Completion Date :	March 2009
Estimated Study Completion Date :	March 2010

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Nicky HG Peters, MD	0031302503196	n.peters@umcutrecht.nl
Contact: Petra HM Peeters, MD PhD	0031302509363	p.h.m.peeters@umcutrecht.nl

Locations

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

Sponsors and Collaborators

UMC Utrecht

Investigators

Study Director:	Willem P Mali, MD PhD	UMC Utrecht

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Porf. dr. W. Mali / Prof. dr. P. Peeters, University Medical Center Utrecht
ClinicalTrials.gov Identifier:	NCT00302120 History of Changes
Other Study ID Numbers:	UMC Utrecht
First Posted:	March 13, 2006
Last Update Posted:	June 10, 2008
Last Verified:	June 2008

Keywords provided by UMC Utrecht:

Magnetic Resonance Imaging; Breast Neoplasms; Diagnostic Trial

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases