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The MONET - Study: MR Mammography of Nonpalpable Breast Tumors

NCT ID: NCT00302120

Last Updated: 2008-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2010-03-31

Brief Summary

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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

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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).

Conditions

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Breast Neoplasms

Keywords

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Magnetic Resonance Imaging Breast Neoplasms Diagnostic Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Contrast-enhanced MR mammography

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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University Medical Center Utrecht

Principal Investigators

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Willem P Mali, MD PhD

Role: STUDY_DIRECTOR

UMC Utrecht

Locations

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Meander Medisch Centrum

Amersfoort, , Netherlands

Site Status RECRUITING

Albert Schweitzer Ziekenhuis

Dordrecht, , Netherlands

Site Status RECRUITING

Unicersity Medical Center Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Nicky HG Peters, MD

Role: CONTACT

Phone: 0031302503196

Email: [email protected]

Petra HM Peeters, MD PhD

Role: CONTACT

Phone: 0031302509363

Email: [email protected]

References

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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. doi: 10.1186/1745-6215-8-40.

Reference Type DERIVED
PMID: 18045470 (View on PubMed)

Other Identifiers

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UMC Utrecht

Identifier Type: -

Identifier Source: org_study_id