DCE-MRI Guided Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- To measure the reproducibility of qDCE-MRI measurement of BRPC.
研究概览
简要总结
The goal of this study is to test whether chemotherapy guided by a new imaging method named DCE-MRI can more effectively reduce a pancreatic tumor, enabling curable surgery, over the conventional method when a tumor is categorized as borderline resectable pancreatic cancer. UAB radiological research team has been studying a cutting-edge imaging technique named dynamic contrast-enhanced magnetic resonance imaging, or DCE-MRI, for over 10 years. This technique has been globally used to calculate the blood flow of various tissues, including tumors. Blood flow often serves as a critical indicator showing a disease status. For example, a pancreatic tumor typically has low blood flow, so it can be used as an indicator to identify the presence of a pancreatic tumor. In addition, an effective therapy can result in the increase of blood flow in a pancreatic tumor during the early period of treatment. Therefore, the investigators may be able to determine whether the undergoing therapy is effective or not by measuring the change of blood flow in the pancreatic tumor and deciding whether to continue the therapy or try a different one.
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
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age 19 years or older).
- •Patients with newly diagnosed and untreated borderline resectable pancreatic cancer.
- •Patients with signed informed consent.
排除标准
- •Any history of prior radiation or chemotherapy or surgical removal for pancreatic cancer.
- •Participants with safety contraindications to MRI examination (determined by standard clinical screening).
- •Participants who are pregnant, lactating or are planning to become pregnant during the study.
- •Participants who are planning to father a child during the study.
结局指标
主要结局
To measure the reproducibility of qDCE-MRI measurement of BRPC.
时间窗: 6 weeks +/- 2 weeks
The pharmacokinetic (PK) parameter within the region of interest (ROI) will be averaged at each scan after P4-based error correction, and the mean values of two scans will be compared to calculate the reproducibility coefficient (%RDC) using the equation, %RDC=2.77wCV, where wCV is the within-subject coefficient of variation. The %RDC before P4-based error correction will also be calculated for comparison. Data reproducibility will be assessed using the intra-class correlation coefficient (ICC) as well. ICC = σ 2b / (σ 2b+ σ 2w), where σb is between-subject standard deviation and σw is within-subject standard deviation.
次要结局
未报告次要终点
研究者
Harrison Kim
Professor, Division of Advanced Medical Imaging Research
University of Alabama at Birmingham
