The Role of 3-Deoxy-3[18]Fluorothymidine Positron Emission Tomography (FLT-PET) in Proliferation of Colorectal Liver Metastases
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- correlation FLT-uptake in colorectal liver metastases and the histologically determined proliferation
研究概览
简要总结
The aim of the study is to obtain information on FLT used in a PET-scan as a marker for the proliferation of colorectal liver metastases, so that the risk of recurrence can be identified in a noninvasive way, concerning patients with resectable colorectal liver metastases.
The hypothesis of this study is that a higher uptake of FLT in the liver metastases has a good correlation with the proliferation rate of the metastases. This rate is related to the risk of recurrence.
详细描述
Aim of the Study:
Validation of FLT-PET as a proliferation marker for colorectal liver metastases, so that the risk of recurrence in patients with resected colorectal liver metastases can be assessed in a noninvasive method.
Study Design:
Validation study (n=40) to determine the correlation between quantitative FLT-PET (in this study determined before resection of the colorectal liver metastases) and the histologically determined proliferation index in the resected specimen of the metastases ('golden standard'). If correlation is established, the correlation between the proliferation and recurrence rate studied is also (n=80).
Study Population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Colorectal liver metastases deemed resectable on three-phase computed tomography (CT)-scan of the liver
- •No evidence of extrahepatic disease on CT chest and abdomen and possible fluorodeoxyglucose (FDG)-PET (if part of surgical work-up)
- •No evidence of local recurrence or second primary colorectal tumor on colonoscopy or colonography
- •Primary colorectal tumor radically removed
- •Informed consent
排除标准
- •Pregnancy
- •Recent chemotherapy
结局指标
主要结局
correlation FLT-uptake in colorectal liver metastases and the histologically determined proliferation
次要结局
- correlation FLT and recurrence rate