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.

The objective of our study is to to assess the diagnostic performance of 7T CE
breast MRI in comparison to the current clinical standard of 3T MRI and
histopathology on a intra-individual basis.

This is a prospective cross-sectional study.

The patient burden consists of an MRI examination form that needs to be filled
out before entering the MRI area. An iv catheter will be inserted to administer
the contrast agent used during the MRI exam, before each of the exams. The
patient will undergo two MRI exams, on two separate days.

As far as is known there are no short- or long term risks involved in having an
MRI scan. Some patient will experience light flashes or tingling due to the
very high magnetic field, especially at 7T. This will immediately disappear as
soon as leaving the magnetic field. Participants are not requested to take any
precautions or actions following to or prior to the MRI exam.

The contrast agent administered during the exam is daily used in clinical
practice during imaging. In rare cases an allergic reaction can occur, such as
an itch, nausea or small bumps on the skin. In the vast majority of cases these
symptoms pass quickly. In extremely rare cases acute allergic reactions can
occur, in patients known with contrast allergies, which do require treatment.
Therefore these patients are excluded from participation in this study.
Furthermore, patients with renal impairment (GFR <30mL/min/1.73m2) are excluded
because of the associated risk of NSF when receiving a gadolinium based
contrast agent. For safety reasons at all times a patient is scanned on the 7T
MRI and contrast is given a medical doctor will be present.