Very Early Response Monitoring in Patients With Glioblastoma Undergoing Therapy Using FDG PET/CT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Changes in glucose uptake
研究概览
简要总结
This pilot clinical trial studies fluordeoxyglucose (fludeoxyglucose) F-18 (FDG) positron emission tomography (PET)/computed tomography (CT) in monitoring very early therapy response in patients with glioblastoma. Diagnostic procedures, such as FDG PET/CT, may help measure a patient's response to earlier treatment. Chemotherapy can induce very rapid changes to the tumor's glucose consumption which can be measured with imaging. FDG PET/CT shortly after the start of therapy may help identify very early therapy response in patients with glioblastoma.
详细描述
PRIMARY OBJECTIVES:
I. To assess very early response to therapy in glioblastoma patients using 18F-FDG PET/CT.
II. Evaluate very early changes in FDG uptake within 48 hours of start of therapy and correlate them with objective response parameters such as Response Assessment in Neuro-Oncology (RANO) and survival.
OUTLINE:
Patients undergo standard FDG PET/CT scan 6-8 weeks before start of chemotherapy and one additional FDG PET/CT scan within 48 hours of the start of chemotherapy.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven high grade glioma
- •Intention to start therapy
排除标准
- •Severe psychiatric illness
- •Inability to give written consent
- •Breast feeding / pregnancy
研究组 & 干预措施
Treatment (FDG PET/CT)
Patients undergo standard FDG PET/CT scan 6-8 weeks before start of chemotherapy and one additional FDG PET/CT scan within 48 hours of the start of chemotherapy.
干预措施: Computed Tomography (Procedure)
Treatment (FDG PET/CT)
Patients undergo standard FDG PET/CT scan 6-8 weeks before start of chemotherapy and one additional FDG PET/CT scan within 48 hours of the start of chemotherapy.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Changes in glucose uptake
时间窗: From baseline up to 48 hours
Standardized uptake values (SUV) will be calculated for different organs and for regions of tumor. Further, regional target to background count-activity ratios will be established.
Very early changes in tumor glucose uptake predictive for objective treatments response and survival assessed using RANO criteria
时间窗: One PET/CT 48 hours after start of therapy
SUV will be calculated for different organs and for regions of tumor. Further, regional target to background count-activity ratios will be established.
次要结局
未报告次要终点