PET Imaging of Ovarian Carcinoma With 18F-FSPG
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- Number of lesions detected by (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET imaging before and after neoadjuvant chemotherapy treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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).
研究组 & 干预措施
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).
干预措施: (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) (Drug)
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).
干预措施: Positron Emission Tomography (Procedure)
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).
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Number of lesions detected by (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET imaging before and after neoadjuvant chemotherapy treatment
时间窗: Up to 2 years
Lesion (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET standard uptake values
时间窗: Up to 2 years
Number of lesions detected by(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET
时间窗: Up to 2 years
次要结局
- 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)
研究者
Marta Crispens, MD
Professor
Vanderbilt-Ingram Cancer Center