68Ga-PSMA PET in Diagnosing Metastasis in Patients With Ovarian Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
PRIMARY OBJECTIVES:
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To determine the feasibility and utility of 68Ga-PSMA PET imaging patients with ovarian cancer.
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Determine detection sensitivity for nodal metastases for PSMA PET stratified by node size.
SECONDARY OBJECTIVES:
- To assess the correlation between targeted molecular uptake of 68Ga-PSMA PET and PSMA expression in surgical resection specimens.
EXPLORATORY OBJECTIVES:
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To explore heterogeneity of 68Ga-PSMA PET uptake in cases of metastatic ovarian cancer.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Diagnostic 68Ga PSMA PET/MRI 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
Given IV
Other Names:
Procedure: Magnetic Resonance Imaging (MRI)
Given PET/MRI
Other Names:
Procedure: Positron Emission Tomography (PET)
Undergo PET/MRI
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of gallium Ga 68-labeled PSMA-11 positron emission tomography (PET) positive lesions detected by standard staging scans [Study Visit Day 1]
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.
- Number of overall ovarian cancer lesions detected by standard staging scans [Study Visit Day 1]
Will be descriptively reported for each patient and correlated with the lesions observed in standard imaging CT/MRI.
- Average maximum standard uptake value (SUVmax) [Study Visit Day 1]
The mean, range, and standard deviation of SUVmax across all visualized lesions per patient will be descriptively reported.
- Number of lymph nodes detected by PET [Study Visit Day 1]
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.
- Number of lymph nodes detected by MRI [Study Visit Day 1]
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.
Secondary Outcome Measures
- Correlation between targeted molecular uptake of 68Ga-PSMA PET and prostate-specific membrane antigen (PSMA) expression in surgical resection specimens [Study Visit Day 1]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with one of the following, identified on prior imaging (CT, MRI or
Ultrasound):
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adnexal mass
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abdominal or pelvic tumor suspicious for ovarian cancer metastases (either suspected on clinical grounds, or known from prior tissue sampling)
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Female,
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Age >= 18 years
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Creatinine </= 1.5 mg/dL
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Ability to understand a written informed consent document, and the willingness to sign it
Exclusion Criteria:
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Pregnant or breastfeeding women
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Patient unlikely to comply with study procedure, restrictions and requirements and judged by the investigator to be unsuitable for study participation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, San Francisco | San Francisco | California | United States | 94115 |
Sponsors and Collaborators
- University of California, San Francisco
- Radiological Society of North America
Investigators
- Principal Investigator: Michael Ohliger, MD, PhD, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 174017
- NCI-2018-02331