Incremental Value of Magnetic Resonance Imaging in Selection of Pancreatic Cancer Patients for Surgery (MAGIPAC): A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Change in treatment strategy
研究概览
简要总结
The aim of the study is to examine the incremental value of using magnetic resonance imaging (MRI) in addition to computed tomography (CT) in the diagnostic workup of pancreatic cancer patients.
详细描述
The aim of the study is to examine the incremental value of using magnetic resonance imaging (MRI) in addition to computed tomography (CT) in the diagnostic workup of pancreatic cancer patients. We will conduct a nationwide, prospective clinical trial to examine the incremental value of using MRI for identification of liver metastases in pancreatic cancer patients.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pancreatic cancer patients considered to have a locally resectable or borderline resectable tumor by the local hepato-pancreato-biliary multidisciplinary team board
- •No liver metastases on CT
- •At least 18 years old and able to provide informed consent
- •Expected pancreatic ductal adenocarcinoma based on CT scan
排除标准
- •Metastatic disease
- •Prior receipt of neoadjuvant chemotherapy or downstaging/-sizing treatment
- •Comorbidity rendering major surgery unfeasible (inoperable)
- •No informed consent
- •Unable to undergo MRI (Kidney insufficiency (eGFR < 60 ml/min/1.73 m2 body surface ar-ea); Claustrophobia; Cardiac pacemaker)
- •Postoperative histology other than adenocarcinoma of pancreato-biliary origin.
- •MRI with liver-specific contrast performed during standard workup.
研究组 & 干预措施
Preoperative MRI
MRI before surgery.
干预措施: Preoperative MRI (Diagnostic Test)
结局指标
主要结局
Change in treatment strategy
时间窗: 1 week
Change in treatment strategy from intended curative resection to other treatment based on MRI scan
次要结局
- Surgery(1 month)
- Intraoperatively detected liver metastases(1 month)
- Liver metastases(1 week)
- Overall survival (1-year)(1 year)
- Resection(1 month)
- Overall survival (3-year)(3 years)
- Recurrence-free survival(3 years)
- Healthcare costs(3 years)