Evaluation of CT Perfusion Parameters as a Potential Biomarker for Treatment Response in Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Correlation between pre-treatment CT tumor perfusion parameters and tumor response after treatment
研究概览
简要总结
This pilot clinical trial studies how well computed tomography (CT) perfusion images work in assessing treatment response in patients with pancreatic cancer. Analyzing specific measurements on the CT perfusion images may help doctors better determine how a tumor responds to chemotherapy and/or radiation therapy and may help guide treatment for patients with pancreatic cancer.
详细描述
OUTLINE:
Patients undergo CT perfusion sequence during the first 40 seconds of the baseline standard of care CT scan and during follow-up CT scans at 2 and possibly 4 months after chemotherapy, at 4-6 weeks after radiation therapy, or prior to definitive surgery.
After completion of the study, patients are followed up periodically for 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Signed informed consent form
- •A diagnosis of pancreatic ductal adenocarcinoma
排除标准
- •Patients unable to provide informed consent
- •Women who are pregnant or intending to become pregnant during the study
- •Patients with body mass index greater than 40 kg/m^2
- •History of severe allergic-like reaction to iodinated contrast media
结局指标
主要结局
Correlation between pre-treatment CT tumor perfusion parameters and tumor response after treatment
时间窗: Up to 1 year
Will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Assessed using logistic regression. ROC curve analysis will be used to examine the sensitivity and specificity of different thresholds for each parameter. If multiple perfusion parameters are found to be predictive of response, a multivariate logistic regression model will be constructed with these variables. ROC analysis will also be used to summary the predictive performance of the multivariate model.
Change in CT tumor perfusion parameter (blood volume)
时间窗: Baseline to post-treatment (up to approximately one year)
The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated. These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test.
Correlation between pre-treatment computed tomography (CT) tumor perfusion parameters and percentage of patients who achieve curative (R0) surgical resection after neoadjuvant chemotherapy
时间窗: Up to 4 years
Assessed using logistic regression. Receiver operating characteristic (ROC) curve analysis will be used to examine the sensitivity and specificity of different thresholds for each parameter.
Correlation of pre-treatment CT tumor perfusion parameters with overall survival
时间窗: At 2 years
Assessed using Cox regression models. Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival.
Correlation of pre-treatment CT tumor perfusion parameters with progression free survival
时间窗: At 2 years
Assessed using Cox regression models. Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival.
Change in computed tomography (CT) tumor perfusion parameters (time to peak concentration)
时间窗: Baseline to post-treatment (up to approximately one year)
The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated. These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test.
Change in CT tumor perfusion parameter (Ktrans)
时间窗: Baseline to post-treatment (up to approximately one year)
The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated. These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test.
Change in CT tumor perfusion parameter (blood flow)
时间窗: Baseline to post-treatment (up to approximately one year)
The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated. These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test.
次要结局
未报告次要终点