Breast Carcinoma Clinical Trial
Official title:
64Cu-DOTA-B-Fab as A PET Tracer for Evaluating CA6 Expression in Tumors: A First in Human Study
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.
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