The MONET - Study: MR Mammography of Nonpalpable Breast Tumors

Breast Neoplasms Clinical Trial

— MONET  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00302120
• Other study ID #: UMC Utrecht
• Status: Recruiting
• Phase: Phase 4
• First received: March 10, 2006
• Last updated: June 9, 2008
• Start date: February 2006
• Est. completion date: March 2010

Study information

• Verified date: June 2008
• Source: UMC Utrecht
• Contact: Nicky HG Peters, MD
• Phone: 0031302503196
• Email: n.peters[@]umcutrecht.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: March 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Procedure:
• Contrast-enhanced MR mammography

Locations

Country	Name	City	State
Netherlands	Meander Medisch Centrum	Amersfoort
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht
Netherlands	Unicersity Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The absolute number of surgical procedures in women with nonpalpable malignancies will be compared between MRI group and control group.		2010	No
Secondary	The number of large core needle biopsies that can be prevented because of a definite diagnosis as provided by MRI will be calculated.		2009	No