Evaluation of Diagnostic Efficacy of Perfusion CT Using Wide Detector for Staging and Response Prediction After Chemotherapy in Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Evaluation of the correlation between the initial perfusion parameters of the tumor and response of the chemotherapy
研究概览
简要总结
The purpose of this study is
- to determine whether the perfusion parameters in the normal pancreas and the pancreas cancer (adenocarcinoma or neuroendocrine tumor) are different on perfusion CT
- to determine whether initial perfusion parameters as well as perfusion parameter change in pancreas adenocarcinoma before and after chemotherapy are different between chemotherapy response group (CR, PR according to RECIST 1.1) and non response group (SD, PD according to RECIST 1.1).
详细描述
- Performance of preoperative perfusion CT for preoperative staging is assessed by comparing with operative finding and histologic disease staging
- Estimation of initial or change of pancreas cancer perfusion parameters and whether those can provide cut-off value for predicting response of chemotherapy in patients with pancreas adenocarcinoma
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •patients who are older than eighteen years
- •patients in whom operation and preoperative computed tomography are scheduled for resectable pancreas adenocarcinoma or pancreas neuroendocrine tumor
- •patients in whom chemotherapy is scheduled for histologically confirmed pancreas adenocarcinoma
- •patients in whom chemotherapy is planned for highly suspicious pancreas adenocarcinoma on imaging workup
- •patients who agree with the study and whose informed consent is obtained.
排除标准
- •patients who are younger than eighteen years old
- •patients in whom previously radiation therapy was performed and the RTx field includes pancreas
- •patients with recurred pancreas adenocarcinoma
- •patient who are pregnant or nursing patients
- •patients with renal failure (GFR<30mL/min)
- •patients with history of malignancy, except malignancy is in complete remission after operation or iodine therapy for at least five years)
- •patients with hypersensitivity for iodine or contrast media or other causes of contraindication of contrast-media enhanced CT scan
- •Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrollment or could interfere with the completion of the study.
研究组 & 干预措施
Resectable pancreas cancer
patients with resectable pancreas adenocarcinoma or neuroendocrine tumor underwent perfusion CT after intravenous iopromide administration
干预措施: iopromide (Drug)
Resectable pancreas cancer
patients with resectable pancreas adenocarcinoma or neuroendocrine tumor underwent perfusion CT after intravenous iopromide administration
干预措施: CT (Procedure)
Locally advanced Pancreas cancer
Patients with locally advanced pancreas cancer underwent perfusion CT after intravenous iopromide administration before and after chemotherapy.
干预措施: iopromide (Drug)
Locally advanced Pancreas cancer
Patients with locally advanced pancreas cancer underwent perfusion CT after intravenous iopromide administration before and after chemotherapy.
干预措施: CT (Procedure)
结局指标
主要结局
Evaluation of the correlation between the initial perfusion parameters of the tumor and response of the chemotherapy
时间窗: after 6 cycles of the planned chemotherapy
Initial perfusion parameters (blood volume, blood flow and permeability) are compared between CTx-responder and non-responders after 6 cycle of the scheduled chemotherapy, using RECIST 1.1 criteria.
次要结局
- Correlation between change of perfusion parameters and the chemotherapy response(after 6 cycles of the chemotherapy)
- Perfusion parameters among different pancreas tumors(within 2 months after finishing enrollment)
- comparison of perfusion parameters among the pancreas tumors and parenchyma(within three weeks before pancreas tumor surgery)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital