FDG PET and DCE-MRI in Predicting Response to Treatment in Patients With Breast Cancer

PRIMARY OBJECTIVES:

I. To determine whether detailed kinetic analysis of FDG PET and magnetic resonance (MR)
imaging studies for measures of tumor metabolism and blood perfusion can predict response and
outcome for breast cancer patients undergoing neo-adjuvant therapy.

II. To compare the in vivo tumor biology associated with responsive and resistant tumors as
measured by kinetic changes in FDG PET and MR imaging parameters to tumor subtypes analyzed
from assay of pre-therapy biopsy and post-therapy surgical tissue.

OUTLINE:

Patients undergo FDG PET and DCE-MRI 1-2 weeks before prior to chemotherapy initiation,
between 1-12 weeks after initiation of the first course of chemotherapy, and after the
completion of chemotherapy (within 4 weeks prior to surgery).

Inclusion Criteria:

- Pathologically confirmed breast cancer, determined to be a candidate for primary
systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor
following completion of neoadjuvant therapy

- Primary tumor 2.0 cm or greater, and/or clinical evidence of axillary disease
(palpable N1 or N2 or biopsy proven)

- No obvious contraindications for primary chemotherapy

- Able to lie still for PET and MRI scanning

- Able to understand and willing to sign a written informed consent document and a
Health Insurance Portability and Accountability Act (HIPAA) authorization in
accordance with institutional guidelines

Exclusion Criteria:

- Serious systemic illness other than breast cancer

- Contraindication to MRI or history of adverse reaction to gadolinium

- Evidence of distant disease outside of regional lymph nodes

- Pregnant

- Poorly controlled diabetes mellitus (fasting blood glucose > 200)

- Prior systemic cancer therapy