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

Study Overview
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Brief Summary
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This trial studies how well gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 (68Ga-PSMA) positron emission tomography (PET) works in patients with ovarian cancer to detect whether the tumor has spread to other places in the body. 68Ga-PSMA is a radioactive substance that binds to blood vessels around the ovarian cancer and can be imaged using PET. Diagnostic procedures, such as PET, may help find and diagnose find out how far the disease has spread.

Detailed Description
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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.

Official Title
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Gallium-68 Prostate Specific Membrane Antigen for Ovarian Cancer: A Pilot Feasibility Study

Conditions
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Ovarian Carcinoma

Intervention / Treatment
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* Drug: Gallium Ga 68-labeled PSMA-11
* Procedure: Magnetic Resonance Imaging (MRI)
* Procedure: Positron Emission Tomography (PET)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with one of the following, identified on prior imaging (CT, MRI or Ultrasound): adnexal mass abdominal or pelvic tumor suspicious for ovarian cancer metastases (either suspected on clinical grounds, or known from prior tissue sampling) Female, Age >= 18 years Creatinine </= 1.5 mg/dL Ability to understand a written informed consent document, and the willingness to sign it Exclusion Criteria: Pregnant or breastfeeding women Patient unlikely to comply with study procedure, restrictions and requirements and judged by the investigator to be unsuitable for study participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic 68Ga PSMA PET/MRI<br>Patients receive gallium Ga 68-labeled PSMA-11 IV over 1-2 minutes. After about 60 minutes, patients undergo PET/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. | Drug: Gallium Ga 68-labeled PSMA-11<br>* Given IV<br>* Other names: PSMA-HBED-CC GA-68;Procedure: Magnetic Resonance Imaging (MRI)<br>* Given PET/MRI<br>* Other names: Nuclear Magnetic Resonance Imaging (NMRI);Procedure: Positron Emission Tomography (PET)<br>* Undergo PET/MRI<br>* Other names: proton magnetic resonance spectroscopic imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of gallium Ga 68-labeled PSMA-11 positron emission tomography (PET) positive lesions detected by standard staging scans | Will be descriptively reported for each patient and correlated with the lesions observed in standard imaging computed tomography/magnetic resonance imaging (CT/MRI). In addition, the mean, range, and standard deviation of standardized uptake value maximum (SUVmax) (across all visualized lesions per patient) and SUVmax-average (ave) (across all patients in the study cohort) will be descriptively reported. | Study Visit Day 1 | 
| Number of overall ovarian cancer lesions detected by standard staging scans | Will be descriptively reported for each patient and correlated with the lesions observed in standard imaging CT/MRI. | Study Visit Day 1 | 
| Average maximum standard uptake value (SUVmax) | The mean, range, and standard deviation of SUVmax across all visualized lesions per patient will be descriptively reported. | Study Visit Day 1 | 
| Number of lymph nodes detected by PET | Will be compared and stratified by lymph node size. For patients undergoing surgical resection, this will be compared with the number of involved lymph nodes by surgical resection. For lymph nodes that are not resected, the behavior on follow-up clinical CT scans (if available) will be used to assess for involvement. | Study Visit Day 1 | 
| Number of lymph nodes detected by MRI | Will be compared and stratified by lymph node size. For patients undergoing surgical resection, this will be compared with the number of involved lymph nodes by surgical resection. For lymph nodes that are not resected, the behavior on follow-up clinical CT scans (if available) will be used to assess for involvement. | Study Visit Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between targeted molecular uptake of 68Ga-PSMA PET and prostate-specific membrane antigen (PSMA) expression in surgical resection specimens | For patients undergoing surgical resection, the 68Ga PSMA-PET uptake will be correlated with PSMA expression in the primary tumor as well as metastatic sites. PSMA expression measurement is available as a core service from the cancer center | Study Visit Day 1 |