An Exploratory, Phase I, Open Label, Multi-Center, Non-randomized Study of [F18]CP-18 PET in Normal and Breast Cancer Subjects

Inclusion Criteria:

For Normal Volunteers

- Subject is a female or male of any race / ethnicity between 21 to 75 years old at the
time of the investigational product administration

- Subject or subject's legally acceptable representative provides written informed
consent

- Subject is capable of complying with study procedures

- Subject must have renal functions values as defined by laboratory results within the
following ranges:

- Serum creatinine ≤ 2x institutional upper limits of normal

For Cancer Patients

- Patient is a female or male of any race / ethnicity between 21 to 75 years old at the
time of the investigational product administration

- Patients or subject's legally acceptable representative provides written informed
consent

- Patient is capable of complying with study procedures

- Patient must have renal functions values as defined by laboratory results within the
following ranges:

- Serum creatinine ≤ 2x institutional upper limits of normal

- BUN < 2X institutional upper limits of normal

- Patient must have a confirmed diagnosis of stage IIB/IIIA/IIIB, locally advanced
breast cancer

- Patient has been or will be scheduled for the surgical resection of tumor(s) after
undergoing neoadjuvant treatment and within approximately 7 days following the
[F-18]CP-18 PET/CT scan

- Patient has an adequate size breast tumor (≥1.0 cm) that should be amenable to
imaging

- Patient's tumor tissue is obtainable following surgery in order to perform
immunohistochemistry staining using caspase 3 and/or other apoptosis biomarkers

- Patient must have a previous baseline (pre-neoadjuvant treatment) diagnostic imaging
exam including but not limited to MRI, CT, mammography, or [F-18] FDG PET/CT scan
that identifies breast tumor location

Exclusion Criteria:

For Normal Volunteers

- Subject is nursing

- Subject is pregnant

- Subject has been involved in an investigative, radioactive research procedure within
the past 14 days

- Subject has any other condition or personal circumstance that, in the judgment of the
investigator, might interfere with the collection of complete data or data quality

For Cancer Patients

- Subject is nursing

- Subject is pregnant

- Subject has been involved in an investigative, radioactive research procedure within
the past 14 days

- Subject has any other condition or personal circumstance that, in the judgment of the
investigator, might interfere with the collection of complete data or data quality

- Patient tumor tissue(s) is not obtainable after tumor resection for caspase 3 and/or
other biomarker immunohistochemistry assays

- Patient has had or will have treatment intervention(s) between the [F-18]CP-18 PET/CT
scan and tumor resection

- Patient has a history or current evidence of any condition, therapy, lab abnormality
that, in the opinion of the study investigator or treating physicians might confound
the results of the study or poses an additional risk to the patients by their
participation in the study