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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Diagnostic Active 18 to 75 Other UMC Utrecht NCT00302120

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

University Medical Center Utrecht

Willem P Mali, MD PhD

Study Director

Nicky HG Peters, MD		Ph: 0031302503196
		Email: n.peters@umcutrecht.nl

Petra HM Peeters, MD PhD		Ph: 0031302509363
		Email: p.h.m.peeters@umcutrecht.nl

Netherlands
	Amersfoort
	Meander Medisch Centrum
	Dordrecht
	Albert Schweitzerziekenhuis - Locatie Amstelwijck
	Utrecht
	University Medical Center Utrecht

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00302120
Information obtained from ClinicalTrials.gov on July 16, 2008