Chemotherapy Monitoring With Breast Computed Tomography (CT)

Before undergoing surgery to remove the tumor, it is common for breast cancer patients to
first undergo chemotherapy or hormonal therapy. The main goal of the therapy is to reduce
the size of the tumor before it is removed. Unfortunately, therapy response varies a lot
between patients. The development of an effective therapy response monitoring method could
reduce the time that a patient undergoes ineffectual therapy or unnecessary therapy after
complete response.

Dedicated breast computed tomography (or breast CT), a new way of imaging the breast, has
been introduced in the last few years. Breast CT is an x-ray exam that uses 3D imaging to
show the breast in its real three dimensional shape. Combined with the use of special
chemicals called iodine contrast enhancement, breast CT can provide images of both the
anatomy and the blood flow in the breast. We propose to use breast CT to carefully monitor
the response to therapy of breast cancer patients undergoing therapy before surgery.

3.1 Eligibility Criteria

- All subjects will be women at least 18 years of age that will undergo standard or
research pre-operative hormonal therapy for breast cancer before lumpectomy or
mastectomy.

- Women who have undergone pre treatment breast MR imaging to verify that no additional
findings are present.

3.2 Ineligibility Criteria

- Subject does not meet any of the inclusion criteria

- Women with suspected or confirmed pregnancy

- Women who have had bilateral mastectomy

- Women who are unable to remain in a prone position on the BCT system for the required
amount of time

- Women who cannot give informed consent

- Women with metastasis

- Male subjects

- Women with implants

- Women with breast augmentation, except for unilateral augmentation done for prior
mastectomy

- Women who are allergic to iodine

- Women with physical limitations such as, but not limited to: frozen shoulder, recent
heart surgery, pace maker, neck problems or any other condition that would prohibit
them from lying face down

- Women who have had problems or reactions to contrast, such as nausea/vomiting,
itching, hives, B/P changes, respirator distress, cardiac arrest.

- Women with history of Diabetes, kidney disease, kidney surgery, dialysis, heart
disease-such as Congestive Heart Failure, Multiple Myeloma, Sickle Cell Anemia,
Lupus, Rheumatoid Arthritis or other Autoimmune disease, recent surgery,
chemotherapy, dehydration, high use of NSAIDs such as Ibuprofen