Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- F-18 FDG Tumor Uptake (SUV Max)
研究概览
简要总结
To learn whether Flourine-18 Fluoro-deoxi-glucose positron emission tomography / computed tomography (F-18 FDG PET/CT) and dynamic contrast enhanced magnetic resonance imaging (DCE MRI) are better predictors of response to therapy than the current standard of care (CT or MRI).
详细描述
This is a single arm prospective trial in patients with newly-diagnosed advanced renal cell cancer (RCC) who were scheduled for sunitinib therapy and utilized an extensive panel of quantitative metrics on baseline and interim FDG PET/CT to evaluate the predictive utility of each of these measurements.
The objectives were to evaluate the FDG PET/CT measurement parameters for prediction of prognosis after sunitinib therapy in patients with RCC using histopathologic (post-therapy nephrectomy) or clinical follow-up for validation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Measurable disease by RECIST criteria
- •Pathologic diagnosis of renal cell cancer
- •Advanced (stage IV) renal cell cancer
- •Karnofsky performance status of (KPS>70)
- •Consent to participate in the clinical trial
排除标准
- •Patients who cannot complete a PET/CT scan.
- •Pregnant women.
- •Healthy volunteers.
- •Patients participating in other research protocols will be excluded from this study.
- •Metallic implants (prosthesis, ICD, pacemakers), since these are contraindications for MRI.
研究组 & 干预措施
F-18 FDG PET/CT and DCE MRI
FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po
干预措施: FDG PET CT (Procedure)
F-18 FDG PET/CT and DCE MRI
FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po
干预措施: DCE MRI (Procedure)
F-18 FDG PET/CT and DCE MRI
FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po
干预措施: F-18 Fluoro-deoxi-glucose (Drug)
F-18 FDG PET/CT and DCE MRI
FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po
干预措施: Gadolinium-DTPA (Drug)
F-18 FDG PET/CT and DCE MRI
FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po
干预措施: Sunitinib (Drug)
结局指标
主要结局
F-18 FDG Tumor Uptake (SUV Max)
时间窗: 12 weeks minus baseline
The maximum standardized uptake value (SUVmax) is a measurement of tumor metabolism as determined by the PET scan before and after 12-weeks of sunitinib therapy. Decreased SUVmax correlates to a reduction of tumor metabolism. Increased SUVmax correlates to an increase in tumor metabolism. Reduction or increased SUVmax will be determined as the change from baseline in uptake of F18 FDG. Results were based on the European Organization for Research and Treatment of Cancer (EORTC) for predicting progression free survival. EORTC criteria is a ± 25% change of SUVmax for assessment of progressive disease, stable disease and partial response.
次要结局
- Histopathology(1 day)
- Initial Comprehensive Metabolic Panel(Prior to baseline DCE MRI)
- Adverse Events(up to 12 months)
- Tumor Necrosis(12 weeks)
- Tumor Size by Computed Tomography (CT) Scan(12 weeks)
- Tumor Size by DCE Magnetic Resonance Imaging (MRI) Scan(12 weeks)
- DCE MRI AUC Peak Flow(12 weeks)
- Initial Tumor Size(pre-sunitinib therapy)
研究者
Andrew Quon
Associate Professor of Radiology (Nuclear Medicine
Stanford University