Pilot Study to Evaluate 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography /Computed Tomography (PET/CT) in Prediction of Early Response to Chemotherapy in Ovarian Cancer.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Partial metabolic response (PMR) - A reduction of a minimum of 15-25% in tumour 18FDG SUV after one cycle of chemotherapy, and greater than 25% after more than one treatment cycle.
研究概览
简要总结
We hypothesize that 18FDG Positron Emission Tomography (FDG PET) imaging, carried out after the first cycle of chemotherapy, will identify responders, thus permitting early termination of potential toxic therapy in non- responders leading to a significant decrease in morbidity and cost. The value of PET imaging as an early predictor of response to chemotherapy has been shown in other cancers.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven ovarian cancer at diagnosis of any stage.
- •Patients with evidence of disease that is radiographically measurable (CT scan)
- •Patients have planned to undergo standard chemotherapy. Dose and schedule will be determined per treating physician
排除标准
- •Patients with any other malignancy active within 5 years except for non-melanoma skin cancer, or carcinoma in situ of the cervix.
- •Patients with an active infection
- •Patients of childbearing potential are excluded from this study.
- •Patients who have expected survival < 3 months.
- •Patients not planning or able to receive the outlined chemotherapy regimen as part of standard practice.
- •Patient unable to complete study
结局指标
主要结局
Partial metabolic response (PMR) - A reduction of a minimum of 15-25% in tumour 18FDG SUV after one cycle of chemotherapy, and greater than 25% after more than one treatment cycle.
时间窗: Completion of study
Complete metabolic response (CMR) - Complete resolution of 18FDG uptake within the tumour volume so that it was indistinguishable from surrounding normal tissue.
时间窗: completion of study
Progressive metabolic disease- increase in 18FDG tumour SUV of greater than 25% within tumour region defined on the baseline scan, visible increase in the extent of 18FDG tumour uptake (>20% in the longest dimension).
时间窗: completion of study
Stable metabolic disease (SMD) -An increase in tumour 18FDG SUV of less than 25% or a decrease of less than 15% and no visible increase in extent of 18FDG uptake in tumor (>20% in the longest dimension).
时间窗: completion of study
次要结局
未报告次要终点