This pilot clinical trial studies copper Cu 64-DOTA-B-Fab positron emission tomography (PET)/computed tomography (CT) in imaging patients with ovarian and breast cancer. Cancer antigen (CA)6 is an antigen (substance) found on the surface of several types of cancer cells such as cancer of the ovary and breast. Diagnostic procedures, such as copper Cu 64-DOTA-B-Fab PET/CT, may help identify CA6 positive tumors and allow doctors to plan better treatment.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
2
Stanford University, School of Medicine
Palo Alto, California, United States
Biodistribution of copper Cu 64 DOTA-B-Fab
Determined from serial imaging correlated with blood and urine samples.
Time frame: 24 hours
Dosimetry of copper Cu 64 DOTA-B-Fab
Determined from serial imaging correlated with blood and urine samples.
Time frame: 120 minutes post-injection
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Correlative studies
Undergo PET/CT