Fluorine F 18 DCFPyL PET/CT and PET/MRI in Imaging Participants with Gynecological Cancer

PRIMARY OBJECTIVES:

I. To establish the biodistribution and radiodosimetry of prostate-specific membrane antigen (PSMA)-based fluorine F 18 DCFPyL (18F-DCFPyL) on PET imaging in normal female controls and in females with known or suspected cancer.

II. To determine the sensitivity, specificity, and accuracy values of PSMA-based 18F-DCFPyL PET and magnetic resonance (MR) imaging in the detection of cancer in women with known or suspected gynecologic malignancy and differentiating cancerous tissue from non-cancerous tissue.

III. To determine the most accurate approach in assessing disease burden and location, assessment of tumor burden on both the PSMA-based 18F-DCFPyL PET and MR imaging together, and then each modality separately will be performed and sensitivity, specificity, and accuracy values will be calculated.

OUTLINE: Participants are assigned to 1 of 2 groups.

GROUP I (CONTROL): Participants that are biodistribution-only receive fluorine F 18 DCFPyL intravenously (IV), after 60 minutes they undergo whole body PET/CT imaging over 120 minutes, and may undergo PET/MRI if PET/CT takes less than 120 minutes. Dosimetry participants receive fluorine F 18 DCFPyL IV inside the scanner and undergo whole body PET/CT imaging over 120 minutes. Dosimetry participants also undergo collection of blood after completion of second, fourth, and fifth PET passes and collection of urine after completion of fourth and fifth PET passes during imaging.

GROUP II (GYNECOLOGICAL CANCER): Participants receive fluorine F 18 DCFPyL IV and gadolinium IV, and after 60 minutes undergo whole body PET/MRI imaging over 90 minutes.

After completion of study treatment, participants are followed up at 1-3 days.