PET Imaging of Ovarian Carcinoma With 18F-FSPG
Overview
- Phase
- Early Phase 1
- Intervention
- (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG)
- Conditions
- Stage IIIA Fallopian Tube Cancer
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Primary Endpoint
- Number of lesions detected by (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET imaging before and after neoadjuvant chemotherapy treatment
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
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.
Investigators
Marta Crispens, MD
Professor
Vanderbilt-Ingram Cancer Center
Eligibility Criteria
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:
- •Adequate performance status, ECOG 0, 1,
- •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.
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.
Arms & Interventions
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).
Intervention: (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG)
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).
Intervention: Positron Emission Tomography
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).
Intervention: Laboratory Biomarker Analysis
Outcomes
Primary Outcomes
Number of lesions detected by (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET imaging before and after neoadjuvant chemotherapy treatment
Time Frame: Up to 2 years
Lesion (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET standard uptake values
Time Frame: Up to 2 years
Number of lesions detected by(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET
Time Frame: Up to 2 years
Secondary Outcomes
- 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)
- 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)
- Proportion of patients whose surgical resection by novel imaging classification changed following validation by histological confirmation(Up to 2 years)