FBnTP Imaging of Breast Cancer

Breast cancer is the most widespread type of cancer among women in the USA, and the second
leading cause of death. The National Cancer Institute estimates that in 2013, in the USA,
226,870 women will be diagnosed with breast cancer and 39,510 women will die of breast
cancer, most of them of progressive metastatic disease. Early detection and treatment of the
disease, when the tumor is still localized and at a high curability state, is the outmost
important determinant of disease-free survival of breast cancer patients. Survival rate of
women first diagnosed with pure early-stage noninvasive tumor (ductal carcinoma in situ-
DCIS) is nearly 98%, which drops to 48% in patients with advanced disease.Yet, early
detection of breast cancer is relatively poor. This is best exemplify by the astonishing
percentage of benign biopsies; 80% of 1.7 million biopsies in the USA, at a cost of $3
billion; whereas, only small fraction (~20%) of newly diagnosed women are found to have pure
DCIS.

Our preclinical studies suggest the capacity of the positron emission tomography (PET)
imaging agent 18F-fluorobenzyl triphenyl phosphonium (FBnTP) to detects early-stage small
breast tumors (e.g., DCIS), and differentiates benign from malignant masses with better
accuracy than that obtained by existing breast imaging tools. Accordingly, the present
protocol is designed to extend the preclinical findings into clinical studies in breast
cancer women, and to assess the effectiveness of 18F-FBnTP in detecting breast malignant
lesions, in comparison with magnetic resonance imaging and fluorodeoxyglucose PET imaging.

Inclusion Criteria:

- Female patients with newly-diagnosed invasive and/or intraductal breast cancer
detected by core needle or vacuum-assisted biopsy (i.e., index cancer)

- Age > 25 Ability and willingness to sign informed consent prior to any study
procedure.

- Positive indication of disease on mammogram or MRI scan.

- Candidate for breast cancer surgery on the basis of recommendation of a breast cancer
surgeon.

- Ability to undergo up to 90 minutes of PEM imaging.

Exclusion Criteria:

- Any active or chronic illness that, in the opinion of the investigators, would make
the study unsafe or limit compliance with study procedures.

- Past or present history of active substance abuse (drug or alcohol).

- Inability to tolerate venous access.

- Pregnant females are excluded from this study. All females of child-bearing potential
will undergo a serum pregnancy test within 48 hours prior to FBnTP administration.