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.

• Computed Tomography (Diagnostic test), also known as CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography: Undergo PET/CT
• Copper Cu 64-DOTA B-Fab (Drug): Given IV
• Laboratory Biomarker Analysis (Other): Correlative studies
• Pharmacological Study (Other): Correlative studies
• Positron Emission Tomography (Diagnostic test), also known as Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging: Undergo PET/CT

Primary outcomes

• Biodistribution of copper Cu 64 DOTA-B-Fab [24 hours]: Determined from serial imaging correlated with blood and urine samples.
• Dosimetry of copper Cu 64 DOTA-B-Fab [120 minutes post-injection]: Determined from serial imaging correlated with blood and urine samples.

Sex: Female, ages: 18 Years to any

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.

• Sanjiv Gambhir, Principal investigator, Stanford University