A Pilot Multi-Institutional Study to Evaluate the Accuracy of a Breast Cancer Locator in Patients With Palpable Cancers

The primary purpose of the study is to determine whether a device called the Breast Cancer
Locator (BCL) accurately identifies the location of cancer in the breast. The Breast Cancer
Locator is a plastic bra-like form that gives the surgeon information about the location of
the cancer in the breast. The location information is derived from an MRI which is obtained
with the patient lying flat on their back (just as they are on an operating room table). The
BCL is then custom made for the patient using 3D printing technology.

The cancer can be felt by the surgeon, and the surgeon will remove the cancer by feeling the
edges of it as the surgeon would normally. Since the cancer can be felt, the surgeon does not
need an image guidance system such as the BCL to locate the cancer in the breast. Other women
may have breast cancers that cannot be felt identified by mammography or MRI. If the BCL
proves to accurately localize breast cancer, it may be a useful guide for the surgeon for
these other women.

Additionally, we want to determine whether this technology can be successfully employed at
multiple sites and what, if any, complications occur during surgery as a result of using this
device. The BCL has been used in 19 patients at Dartmouth with no complications.

Inclusion Criteria:

1. Age > 18 years.

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

3. Patient desire to undergo breast surgery (lumpectomy or non-skin sparing mastectomy).

4. Ability to voluntarily provide informed consent to participate prior to any
study-related assessments/procedures being conducted.

5. The cancer enhances on prone breast MRI imaging

6. The cancer is visible on mammography.

Exclusion Criteria:

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.

6. Patients receiving neoadjuvant chemotherapy.