Trial Information

Magnetic Resonance Imaging (MRI) Correlation to Standard of Care Imaging and Pathology Correlation in Breast Carcinoma

Background Information

In addition to the gold standard imaging of mammography and breast ultrasound, magnetic
resonance imaging (MRI) has become a well established investigational modality for the
diagnosis and staging of breast cancer. MRI demonstrates increased sensitivity and
specificity relative to both mammography and breast ultrasound in the screening of women
with an increased risk of breast cancer development (i.e. familial history of disease and /
or genetic predisposition) and those who have very dense breast tissue. MRI has also proved
to be very sensitive in the detection of multi-focal, multi-centric breast lesions,
permitting the accurate staging of disease. However, despite this demonstrated efficacy, the
standardization of MRI studies from one Institution to another is often difficult as each
Institution will have a standard breast protocol with sequences set in accordance to the
manufacturer of the machine and the manner in which the breast examinations have been
designed.

At the Cross Cancer Institute (CCI) a breast MRI protocol based on the technical procedures
recommended in the literature and personal scanning experience has been developed. However,
due to the limited number of patients undergoing breast MRI examinations, our current
experience is limited relative to the level of expertise demonstrated in the interpretation
of breast ultrasound and mammographic scans. Fortunately, we now have the opportunity to
obtain MRI - pathology correlation as Dr. Kelly Dabbs is performing on site breast cancer
surgery at the CCI. We propose to obtain an MRI examination of all consented patients prior
to their surgical procedure. The MRI results of each patient will then be compared to
previous breast imaging (mammography and breast ultrasound) and histopathological specimens
to determine the correlative accuracy of MRI with these techniques. To assess whether the
size, grade, and presence of lymphovascular invasion or associated ductal carcinoma in situ
influence the accuracy of MR imaging, all breast carcinoma subtypes will be included in this
study.

As a teaching hospital, the CCI provides mammographic and breast ultrasound training to the
Residents and the Diagnostic Radiology Program at the University of Alberta. Although breast
MRI should be part of this training program, we currently do not have the necessary volume
of breast MRI scans to provide Residents with adequate experience in this modality. The
establishment of a breast MRI protocol, one which refers eligible CCI breast cancer patients
for a pre-surgery MRI examination, will promote the development of expertise in this area,
provide Residents with a comprehensive Breast program and keep the CCI at the leading edge
of breast cancer care.

Objectives

Primary Objective: to assess how the MRI of the breast correlates to a standard of care
which includes biopsy, surgery, breast ultrasound and mammography.

Secondary Objective: to assess how the MRI correlates to the breast cancer pathology
collected at the CCI.

Study Design

A research study is proposed with the above information in mind, whereby Dr. Kelly Dabbs
refers consented surgical patients with known breast carcinoma for a pre-surgical breast
MRI. The MRI results will then be reviewed along with the mammograms and breast ultrasounds
and then correlated to pathology findings. The intent will be to correlate all of the
various sub-types of breast carcinoma with MRI, as well as to assess whether or not MRI
demonstrates changes dependent upon the extent lymphovascular invasion, the presence of
associated ductal carcinoma in situ and the size, cellular composition and grade of the
cancer.

Dr. Dabbs will explain the study rational and give the patient a copy of Informed Consent
and, for those patients who are willing to undergo the procedure, schedule a MRI at the CCI.
It is our aim to accrue 50 patients per year for two years, for a total of 100 patients.

Inclusion / Exclusion Criteria

Inclusion criteria:

- Females ? 18 years of age

- Females referred to Dr. Kelly Dabbs for breast cancer surgery who have pathology
positive for breast carcinoma, any sub-type.

Exclusion criteria:

- Pacemakers

- Aneurysm clips

- Cochlear implants

- Epicardial pacemaker wires

- Neural stimulators

- Significant claustrophobia

- Significant obesity that would not enable the patient to fit in the scanner

- Pregnancy or breastfeeding

Recruitment

Surgical patients referred by Dr. Kelly Dabbs will undergo a pre-surgical MRI examination
providing they meet the study eligibility criteria.

Statistical analysis

N/AP

Stopping Rules

The study will end once the first 100 subjects enrolled have undergone their MRI breast
scan.

Data Safety Monitoring Committee

N/AP