Copper Cu 64-DOTA-B-Fab PET/CT in Imaging Patients With Ovarian and Breast Cancer

PRIMARY OBJECTIVES:

I. To determine the dosimetry of 64Cu-DOTA B-Fab (copper Cu 64-DOTA-B-Fab).

SECONDARY OBJECTIVES:

I. To evaluate the safety of 64Cu-DOTA B-Fab single administration.

II. To evaluate the ability of 64Cu-DOTA B-Fab to detect CA6-positive ovarian and breast
cancer lesions.

III. To compare PET results with the immunohistochemistry (IHC) analysis of the excised tumor
samples.

OUTLINE:

Patients receive copper Cu 64-DOTA-B-Fab intravenously (IV) followed by PET/CT 60 minutes
post-injection and 24 hours post-injection

After completion of study, patients are followed up for 12 months.

Inclusion Criteria:

Ovarian Cancer Participants

1. Patient is ≥ 18 years old at the time of the drug administration

2. Participant has suspected or biopsy proven ovarian cancer and is scheduled to undergo
surgical excision of the cancerous lesion(s) OR Participant has biopsy proven ovarian
cancer but is not a surgical candidate

3. Ability to understand and the willingness to sign a written informed consent document.

4. Patient is able to remain still for duration of each imaging procedure

Breast Cancer Participants

1. Patient is ≥ 18 years old at the time of the drug administration

2. Participant has biopsy proven breast cancer and may or may not undergo surgical
excision of the cancerous lesion(s)

3. Ability to understand and the willingness to sign a written informed consent document.

4. Patient is able to remain still for duration of each imaging procedure

Exclusion Criteria:

Ovarian Cancer Participants

1. Patient is pregnant or breast-feeding

2. Patients with contraindications for PET/CT or who cannot complete a PET/CT scan or
other study procedures.

3. Patients with serious uncontrolled concurrent medical illness that would limit
compliance with study requirements

4. Patients participating in other research imaging protocols will be excluded from this
study.

Breast Cancer Participants

1. Patient is pregnant or breast-feeding

2. Patients with contraindications for PET/CT or who cannot complete a PET/CT scan or
other study procedures.

3. Patients with serious uncontrolled concurrent medical illness that would limit
compliance with study requirements

4. Patients participating in other research imaging protocols will be excluded from this
study.