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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
UMC Utrecht

Tracking Information
First Submitted Date  ICMJE March 10, 2006
First Posted Date  ICMJE March 13, 2006
Last Update Posted Date June 10, 2008
Study Start Date  ICMJE February 2006
Estimated Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2008)
The absolute number of surgical procedures in women with nonpalpable malignancies will be compared between MRI group and control group. [ Time Frame: 2010 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 10, 2006)
The absolute number of surgical procedures in women with nonpalpable malignancies will be compared between MRI group and control group.
Change History Complete list of historical versions of study NCT00302120 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2006)
The number of large core needle biopsies that can be prevented because of a definite diagnosis as provided by MRI will be calculated.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The MONET - Study: MR Mammography of Nonpalpable Breast Tumors
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE Procedure: Contrast-enhanced MR mammography
Study Arms  ICMJE Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 10, 2006)
440
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2010
Estimated Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00302120
Other Study ID Numbers  ICMJE UMC Utrecht
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Porf. dr. W. Mali / Prof. dr. P. Peeters, University Medical Center Utrecht
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Willem P Mali, MD PhD UMC Utrecht
PRS Account UMC Utrecht
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP