68Ga-PSMA PET in Diagnosing Metastasis in Patients With Ovarian Cancer

PRIMARY OBJECTIVES:

I. To determine the feasibility and utility of 68Ga-PSMA PET imaging patients with ovarian
cancer.

II. Determine detection sensitivity for nodal metastases for PSMA PET stratified by node
size.

SECONDARY OBJECTIVES:

I. To assess the correlation between targeted molecular uptake of 68Ga-PSMA PET and PSMA
expression in surgical resection specimens.

EXPLORATORY OBJECTIVES:

I. To explore heterogeneity of 68Ga-PSMA PET uptake in cases of metastatic ovarian cancer.

II. To determine the relationship between 68Ga-PSMA PET uptake, diffusion weighted imaging,
and MRI-derived tumor perfusion.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 1-2 minutes. After
about 60 minutes, patients undergo PET/magnetic resonance imaging (MRI) for approximately
over 50-60 minutes. Patients may undergo an optional repeat gallium Ga 68-labeled PSMA-11 PET
between 8 and 12 weeks after completion of the first PET/MRI.

After completion of study, patients are followed up at 28 days.

Inclusion Criteria:

- Patients with suspected or pathologically diagnosed ovarian cancer

- Measurable disease on prior imaging (computed tomography [CT] or magnetic resonance
imaging [MRI]) without interval debulking or treatment

- Creatinine =< 1.5 mg/dL

- Ability to understand a written informed consent document, and the willingness to sign
it

Exclusion Criteria:

- Patients with or with a history of uncontrolled bleeding diathesis

- Patients who have had active infection within 15 days of study enrollment

- Pregnant or breastfeeding women

- Patients with an inability to access an intravenous line