MRI Imaging to Predict Outcomes of Treatment in PDAC Patients
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Rate of progression-free survival from baseline
研究概览
简要总结
The purpose of this study is to assess if Six-Dimensional Magnetic Resonance Imaging (6D-MRI) is effective in predicting outcomes in patients with pancreatic ductal adenocarcinoma (PDAC).
详细描述
The overarching goal of this pilot study is to evaluate the usefulness of a novel Magnetic Resonance Imaging (MRI) approach, which measure properties of tumor microenvironment (i.e. vascularity, fibrosis), to predict PDAC response to neoadjuvant therapy (NAT).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Pancreatic cancer patients (with resectable or borderline resectable or locally advanced tumors) who will undergo neoadjuvant chemotherapy
- •Patients able to undergo at least two sets of MRI sessions
排除标准
- •Patients who have previously been treated for PDAC
- •Patients unable to undergo MRI exam w/contrast
- •Patients with metastatic pancreatic cancer visualized on index diagnostic imaging
- •Patients with certain metallic implants
- •Patients experiencing claustrophobia
- •Persons with allergy to animal dander or animal-instigated asthma
结局指标
主要结局
Rate of progression-free survival from baseline
时间窗: 2 years
Progression-free survival will be determined by tumor activity assessed from radiomic features on imaging.
Number of participants with R0 resection
时间窗: 2 years
The rate of negative tumor resection margins for patient's with resectable cancer that undergo surgery.
Rate of progression-free survival from baseline
时间窗: 2 years
Progression-free survival will be determined by tumor activity assessed from radiomic features on imaging.
Number of participants with R0 resection
时间窗: 2 years
The rate of negative tumor resection margins for patient's with resectable cancer that undergo surgery.
次要结局
未报告次要终点
研究者
Srinivas Gaddam
Associate Director Pancreatic Biliary Research
Cedars-Sinai Medical Center