A Study to Evaluate the Use of Supine MRI Images in Breast Conserving Surgery

We propose to use a novel technique (optical scanning) to correlate the supine MRI image to
the surgical position in the OR and then to confirm and extend the Japanese study described
above. In the first phase of the study, 5-25 patients with palpable invasive breast cancer
will undergo pre-operative supine MRI and optical scanning in the surgical position. The
purpose of this phase will be ensure that the images created from the optical
scanner-adjusted supine MRI images closely correspond to the location of the palpable tumors
in these breasts. All patients will then have their tumor resected using the standard method
of either palpation or image guided wire localization. The first phase has been completed.

In the second phase of the study, patients with non-palpable invasive breast cancer or DCIS
who desire breast conservation will be randomized to either a usual care group, or a group
receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and
undergoing breast cancer resection without the wire localization technique.

Our secondary objectives will be to determine:

1. whether there are differences between the two groups in the volume of breast tissue
removed.

2. whether diagnostic information obtained from a supine MRI is equivalent to that obtained
from the prone MRI.

Inclusion Criteria Phase 1

1. Age greater than/equal to 18 years

2. Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ

3. Patient desire to undergo breast surgery

3. Patients will have provided informed consent to participate, documented by their
signature on the study consent form 4. The cancer enhances on breast MRI imaging.

Inclusion Criteria Phase 2

1. Age greater than/equal to 18 years

2. Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ

3. The tumor is visible and enhances on prone MRI and is >1 cm in greatest diameter.

4. . Determination by the surgeon that the neoplasm is non-palpable.A patient with a
palpable hematoma from core biopsy, but a non-palpable neoplasm, will be eligible for
study

5. Patient desire to undergo breast conserving surgery

6. Patients will have provided informed consent to participate, documented by their
signature on the study consent form.The process of informed consent will be documented
in the medical record and a copy of the signed consent form will be given to the
patient.

Exclusion Criteria (Phases 1 and 2)

1. Absolute contraindication to MRI, including presence of implanted electrical device
(pacemaker or neurostimulator), aneurysm clip or metallic foreign body in or near eyes

2. Severe claustrophobia

3. Contraindication to use of gadolinium based intravenous contrast, including life
threatening allergy or compromised renal function (creatinine > 2.0)

4. History of median sternotomy

5. Pregnancy (Patient attestation that they are not pregnant will be acceptable, as per
standard, as per standard policy for MRIs at DHMC).

6. Multicentric breast cancer, defined as two or more tumors in different quadrants of
the breast. An eligibility worksheet will be completed for each patient prior to
enrollment and will be signed and dated by the surgeon investigator