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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02331 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| Radiological Society of North America | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gallium Ga 68-labeled PSMA-11 | Drug | Given IV |
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| 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. |
| 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 |
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Inclusion Criteria:
Patients with one of the following, identified on prior imaging (CT, MRI or Ultrasound):
Female,
Age >= 18 years
Creatinine \
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The patient population will be women with adnexal masses or other lesions suspicious for ovarian cancer metastases, who are scheduled for either resection or chemotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Michael Ohliger, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36512649 | Derived | Kunikowska J, Bizon M, Pelka K, Derlatka P, Olszewski M, Krolicki L. 68 Ga-Prostate-Specific Membrane Antigen PET/CT in Ovarian Tumors : Potential to Differentiate Benign and Malignant Tumors Before Surgery: A Preliminary Report. Clin Nucl Med. 2023 Feb 1;48(2):e60-e66. doi: 10.1097/RLU.0000000000004486. Epub 2022 Nov 18. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Magnetic Resonance Imaging (MRI) | Procedure | Given PET/MRI |
|
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| Positron Emission Tomography (PET) | Procedure | Undergo PET/MRI |
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| Study Visit Day 1 |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |