The MONET - Study: MR Mammography of Nonpalpable Breast Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by UMC Utrecht.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00302120
First received: March 10, 2006
Last updated: June 9, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Breast Neoplasms
Procedure: Contrast-enhanced MR mammography
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • The absolute number of surgical procedures in women with nonpalpable malignancies will be compared between MRI group and control group. [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 440
Study Start Date: February 2006
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302120

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

No publications provided

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
Study First Received: March 10, 2006
Last Updated: June 9, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Magnetic Resonance Imaging
Breast Neoplasms
Diagnostic Trial

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014