A Study to Evaluate the Use of Supine MRI Images in Breast Conserving Surgery
A Study to Evaluate the Use of Supine MRI Images in Breast Conserving Surgery
This is a 2 Phase study. In the first phase of the study, patients with palpable invasive
 breast cancer underwent pre-operative supine MRI and optical scanning in the surgical
 position. 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.
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