"Contrast-enhanced MR imaging of the breast at 7T and 3T in the same patients".

Every year over 10.000 Dutch women are diagnosed with invasive breast cancer. This makes breast cancer the cancer type with the highest incidence in Dutch women.

When a breast lesion is detected, conventional triple diagnosis, currently with the addition of ultrasound imaging, is performed to establish the diagnosis. Before treatment can be initiated accurate staging needs to be conducted to develop an individualized treatment plan. Staging requires precise knowledge of the size of the Index Lesion is required as well as of the presence or absence of lesions in other quadrants of the breast.

Magnetic resonance imaging has additional value in the staging of breast cancer due to its capability to depict multicentric and multifocal disease, to assess the tumor in a three-dimensional way and to detect lesions in dense breast tissue. In recent years there has been an increasing interest in MRI as a non-invasive diagnostic modality for the work-up of suspicious breast lesions. The sensitivity of MRI for diagnosing breast cancer is over 90% with specificity around 70%.
Recently ultra-high field 7.0 Tesla MRI has become clinically available. The availability of ultra high field 7T MRI offers new diagnostic possibilities: due to the very high magnetic field strength of the scanner, images can be acquired at a higher spatial resolution allowing smaller structural detail to be depicted. For breast cancer this means not just detection of smaller lesions, but also better morphologic classification of detected lesions and better delineation of lesion extent.

The preliminary results of our nearly finished technical feasibility study of CE breast MRI at 7T (NL32664.041.10) has concluded that contrast-enhanced 7T breast MRI is technically feasible and reasonably well tolerated. Both morphology as well as kinetic assessments could be conducted, in accordance with the BI-RADS-MRI criteria. The next step is to assess the diagnostic performance of 7T CE-MRI in comparison with the current diagnostic standard of 3T MRI and histopathology.

This is a prospective cross-sectional study aimed at assessing the diagnostic performance of 7T CE breast MRI compared to the clinical standard of 3T MRI and histopathology, on a intra-individual basis.

Patients with a BI-RADS 4 of higher classification will be submitted to two MRI exams.

The endpoint of follow-up for all included patients will be final histological evaluation.

Two contrast-enhanced breast MRI scans; 7 Tesla MRI & 3 Tesla MRI.