PET Imaging of Ovarian Carcinoma With 18F-FSPG
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental 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)
Given by IV
Procedure: Positron Emission Tomography
Undergo scan
Other: Laboratory Biomarker Analysis
Laboratory Biomarker Analysis
|
Outcome Measures
Primary Outcome Measures
- 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
- Immunohistochemistry evaluation of xC- and CD 44 of resected malignant ovarian cancer with a measurement of strength of staining from 0-3. [Up to 2 years]
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.
- 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 [Up to 2 years]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Have a presumed diagnosis of advanced stage epithelial ovarian, fallopian tube, or peritoneal.
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Pelvic mass and/or omental caking with Ca-125:CEA ratio 25:1.
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Adequate performance status, ECOG 0, 1, 2.
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Adequate organ function:
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PCV > 30 (with or without transfusion)
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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.
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Platelet count > 150, 000 and < 1,000,000
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Cr < 1.5
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LFTS < 1.5 x ULN
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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.
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No prior treatment for ovarian cancer
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have undergone or agree to undergo standard of care imaging for ovarian cancer with CT chest, abdomen, and pelvis.
Exclusion Criteria:
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Have non-invasive or non-epithelial ovarian cancer on pathological confirmation.
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Pregnant and breastfeeding
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Poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL).
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Other poorly controlled medical conditions that in the opinion of the surgeon, make them not a candidate for primary cytoreductive surgery.
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CT of chest, abdomen, pelvis demonstrates:
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Any disease in the thoracic cavity > 1 cm.
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Any suprarenal lymphadenopathy > 1 cm.
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Liver metastases > 1 cm.
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Disease in the porta hepatis or gallbladder fossa > 1 cm.
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Pleural effusion > 50% volume of the chest cavity on chest x-ray.
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Omental extension to the stomach, spleen, or lesser sac.
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Extension to the pelvic sidewall (this criteria may also be assessed on physical examination.
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involvement of the root of the mesentery.
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Decline procedures that might be necessary for optimal primary cytoreduction (i.e. colostomy or splenectomy).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Vanderbilt-Ingram Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Marta Crispens, MD, Vanderbilt University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VICC GYN 15142