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Optimization of MR-Guided percutaneus breast biopsy and evaluation of its clinical value

Objective

Objectives:
Contrast-Enhanced MRI of the breast may be the most sensitive method for the detection of invasive carcinoma and is capable of detecting small non-palpable lesions, which are not visible by other modalities. Its usefulness is, however, limited by the facts that only one of 3-4 MR-detected lesions proves to be a carcinoma, after needle localization detection of non-calcified non-palpable early lesions. This is a problem for gynecologists/surgeons. Additionally MR-guided core biopsy is not yet clinically established. The first MR biopsy coils still had significant disadvantages (limited access to lesions close to the chest wall, access to the breast from only one side, limited accuracy, complicated handling). A second generation prototype biopsy coil will be available 7/97, which promises to fulfill all above requirements.

Brief description:
In this multicenter trial an optimum procedure for MR-guided biopsy should be developed (phase A) and the clinical value of MR-guided biopsy (phase B) shall be tested.
Phase A: The procedure needs to be optimized by people with large experience with percutaneous breast biopsy. The development includes development of appropriate software (together with industry, partner 5). Since experience with percutaneous breast biopsy is still limited in Germany, partners from outside Germany with extensive experience (partners 3 and 4) in this field and worldwide accepted leadership for over 10 years are required.
Phase B: Based on an optimized technique MR-guided percutaneous core biopsy and preoperative localization will first be tested on small mammographically detected lesions (indication 1). It shall then be applied to lesions that are only or best visualized by MR [MR-detected multicentricity in preoperative patients (indication 2), MR-detected lesions in problem cases (indication 3) or in patients with high familial risk of breast cancer (indication 4)]. In order to investigate a high percentage of small lesions, selected recruitment from a screening population (only available from partners 3 and 4) is necessary, while partners 1 and 2 contribute extensive knowledge on MRI of the breast and experience with MR-guided biopsy. Subtropics (= evaluation of MR-guided biopsy for indications 14) will be split among the partners: Partner 1 (indications 2, 3), partner 2 (indications 2, 4), partner 3 (indications 1, 3) and partner 4 (indications 1,4). Successful development of MR-guided percutaneous biopsy will allow to cost-effectively use the high sensitivity of Contrast-Enhanced MRI for improved detection of malignancy in high risk patients with dense breasts.

Keywords:
Biopsy, Contrast-enhanced MRI, MR-guidance, breast cancer, percutaneous core biopsy, vacuum biopsy, localization

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

Martin-Luther-Universität Halle-Wittenberg
Address
16,Magdeburger Strasse 16
06097 Halle
Germany

Participants (4)

Katholieke Universiteit Nijmegen - Stichting Katholieke Universiteit
Netherlands
Address
10,Geert Grooteplein
6500 HB Nijmegen
Ludwig-Maximilians-Universität München
Germany
Address
Marchioninistraße 15
81377 München
Siemens AG
Germany
Address
127,Henkestraße 127
91052 Erlangen
Université de Montpellier 1
France
Address
209,Rue Des Apothicaires 209
34196 Montpellier