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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00302120
Recruitment Status : Unknown
Verified June 2008 by UMC Utrecht.
Recruitment status was:  Recruiting
First Posted : March 13, 2006
Last Update Posted : June 10, 2008
Information provided by:
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.

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).

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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

Resource links provided by the National Library of Medicine

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00302120

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Contact: Nicky HG Peters, MD 0031302503196
Contact: Petra HM Peeters, MD PhD 0031302509363

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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
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Study Director: Willem P Mali, MD PhD UMC Utrecht

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Porf. dr. W. Mali / Prof. dr. P. Peeters, University Medical Center Utrecht Identifier: NCT00302120     History of Changes
Other Study ID Numbers: UMC Utrecht
First Posted: March 13, 2006    Key Record Dates
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:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases