PET Imaging of Ovarian Carcinoma With 18F-FSPG

Study Overview
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Brief Summary
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This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-FSPG [(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid], a glutamic acid derivative, to image patients with ovarian cancer before undergoing surgery or transplant. Diagnostic procedures, such as 18F-FSPG PET, may help find and diagnose ovarian cancer and find out how far the disease has spread.

Official Title
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PET Imaging of Ovarian Carcinoma With 18F-FSPG

Conditions
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Stage IIIA Fallopian Tube Cancer, Stage IIIA Ovarian Cancer, Stage IIIA Primary Peritoneal Cancer, Stage IIIB Fallopian Tube Cancer, Stage IIIB Ovarian Cancer, Stage IIIB Primary Peritoneal Cancer, Stage IIIC Fallopian Tube Cancer, Stage IIIC Ovarian Cancer, Stage IIIC Primary Peritoneal Cancer, Stage IV Fallopian Tube Cancer, Stage IV Ovarian Cancer, Stage IV Primary Peritoneal Cancer

Intervention / Treatment
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* Drug: (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG)
* Procedure: Positron Emission Tomography
* Other: Laboratory Biomarker Analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a presumed diagnosis of advanced stage epithelial ovarian, fallopian tube, or peritoneal. Pelvic mass and/or omental caking with Ca-125:CEA ratio 25:1. Adequate performance status, ECOG 0, 1, 2. Adequate organ function: PCV > 30 (with or without transfusion) WBC: 3000 - 10,000 The lower level of normal for total WBCs is 4,000, but the NCI considers levels of 3,000- 4,000 as mild suppression for drug trials, specifically not requiring treatment. Platelet count > 150, 000 and < 1,000,000 Cr < 1.5 LFTS < 1.5 x ULN Have undergone or have agreed to undergo standard of care CT of the chest, abdomen, and pelvis. 18F-FSPG PET imaging will be performed as investigational studies. No prior treatment for ovarian cancer have undergone or agree to undergo standard of care imaging for ovarian cancer with CT chest, abdomen, and pelvis. Exclusion Criteria: Have non-invasive or non-epithelial ovarian cancer on pathological confirmation. Pregnant and breastfeeding Poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL). Other poorly controlled medical conditions that in the opinion of the surgeon, make them not a candidate for primary cytoreductive surgery. CT of chest, abdomen, pelvis demonstrates: Any disease in the thoracic cavity > 1 cm. Any suprarenal lymphadenopathy > 1 cm. Liver metastases > 1 cm. Disease in the porta hepatis or gallbladder fossa > 1 cm. Pleural effusion > 50% volume of the chest cavity on chest x-ray. Omental extension to the stomach, spleen, or lesser sac. Extension to the pelvic sidewall (this criteria may also be assessed on physical examination. involvement of the root of the mesentery. Decline procedures that might be necessary for optimal primary cytoreduction (i.e. colostomy or splenectomy).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Patients receive (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET scans. Patients undergo PET imaging scans during 0-45 minutes, 60-75 minutes, and 105-120 minutes after injection and within 4 weeks prior to surgery (Cohort A) or within 4 weeks of SOC imaging at diagnosis and prior to subsequent treatment (Cohort B). | Drug: (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG)<br>* Given by IV<br>Procedure: Positron Emission Tomography<br>* Undergo scan<br>Other: Laboratory Biomarker Analysis<br>* Laboratory Biomarker Analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET standard uptake values |  | Up to 2 years | 
| Number of lesions detected by(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET |  | Up to 2 years | 
| Number of lesions detected by (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET imaging before and after neoadjuvant chemotherapy treatment |  | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunohistochemistry evaluation of xC- and CD 44 of resected malignant ovarian cancer with a measurement of strength of staining from 0-3. | All imaging data (SUV) will be correlated to definitive, ex vivo diagnostic pathology and immunoreactivity (xC-, CD44), which will be carried out for every patient with resected tissue. and, when IHC scoring will be in terms of strength of immunostaining (scored on an ordinal scale of 0 3). This treatment of lesion-based sensitivity and specificity has not been previously described in the ovarian cancer literature. | Up to 2 years | 
| Proportion of patients whose surgical resection by novel imaging classification changed following validation by histological confirmation |  | Up to 2 years | 
| Proportion of patients whose response to chemotherapy changed by Response Evaluation Criteria in Solid Tumors criteria |  | Up to 2 years | 
| Conditional predictive models of imaging performance and agreement | We will test that lesion 18F-FSPG PET SUV's are significantly greater than background (normal liver tissue) by tissue assessment of number of lesions noted in each arm and after treatment. | Up to 2 years |