Magnetic Resonance Imaging for Better Selection of Pancreatic Cancer Patients for Surgery: A Randomized Clinical Trial (MAGIPAC)
Magnetic Resonance Imaging for Better Selection of Pancreatic Cancer Patients for Surgery
Pancreatic cancer has the most dismal prognosis with a 5-year survival of 8%. The only curative treatment is surgery which is accompanied by great morbidity and mortality. Recent research indicates that Magnetic Resonance Imaging (MRI) is superior in detecting liver metastases compared with today's gold standard computed tomography (CT), which usually is a contraindication to surgery.
Investigators want to randomize patients with pancreatic cancer, who are eligible for surgery to a pre-operative MRI. The investigators want to examine if MRI is as good for the staging as CT and if MRI is better for the identification of liver metastases. Patients will have a follow-up period of 1 year to see if MRI changes the overall survival.
研究概览
详细说明
Currently, CT is the state of art for assessing and staging pancreatic cancer. However, it has its limitations when it comes to detecting small liver metastases, which are often found in pancreatic cancer. Recent research indicates that MRI is superior to CT when it comes to the detection of liver metastases. Thus, the investigators want to examine MRI's role in the assessment of pancreatic cancer.
The investigators want to conduct a nationwide RCT to examine the feasibility of using MRI for tumor staging and identification. The overall aim is to improve the selection of patients going to surgery so futile resections are avoided and increase the overall survival. Patients who are deemed eligible for pancreatic resection after being reviewed at a local multidisciplinary tumor board will be, upon consent, electronically randomized to one of two treatment arms (each arm will contain 100 patients). Patients within the control arm will as per usual proceed to surgery, whereas patients in the intervention arm will receive a pre-operative MRI scan. The MRI will be read by experienced gastroenterology radiologists who are blinded to the patient's identity and the initial CT findings. Treatment will be based on MRI findings. There will be a follow-up period of 1 year to see if MRI changes the overall survival. Within this RCT we will conduct three studies.
Study 1) The investigators want to compare pancreatic tumor staging with MRI versus standard upper abdominal CT, we hypothesize that MRI is not inferior to CT.
Study 2) The investigators want to assess MRI's ability to detect liver metastases vs standard upper abdominal CT, in patients otherwise deemed eligible for surgery. We hypothesize that MRI is superior to CT in the detection of liver metastases.
Study 3) The investigators want to assess the impact of MRI, thus patients will be followed for 1 year. We want to see if MRI changes the overall survival, treatment allocation, and recurrence.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Christian Flindt Nielsen., Cand. med.
- 电话号码:+4551530041
- 邮箱:Cflindtn@gmail.com
研究联系人备份
- 姓名:Jakob Kirkegaard, PhD
- 电话号码:+4522900604
- 邮箱:jakob.kirkegaard@auh.rm.dk
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Must be eligible for curative pancreatic resection based on CT
- Must accept randomization
Exclusion Criteria:
- Not eligible for curative pancreatic resection
- Unable to undergo MRI.
- Did not accept randomization.
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
无干预:Conventional
Patients who are eligible for surgery are randomized to MRI scan or standard curative surgery.
Patients in this arm will receive standard care according to danish standards without pre-operative MRI scans.
|
|
其他:MRI scan
This arm includes patients who have been randomized to pre-operative MRI scans.
|
Patients will be randomized to a pre-operative scan or not.
The MRI scan will evaluate the local extent of the tumor and especially focus on identifying possible liver metastases unseen on the CT-scan.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Correlation in tumor staging (T- and N-stage) between CT and MR
大体时间:1 year
|
The degree of correlation between CT and MR with respect to T- and N-stage.
Will be assessed using Kappa-values.
|
1 year
|
Proportion of patients with liver metastases in the intervention arm
大体时间:1 year
|
To examine if MRI scans identify more metastases than conventional CT scans.
Measured by the Chi2-test.
|
1 year
|
One-year survival after randomization
大体时间:1 year
|
To examine if MRI scans improves survival of patients with pancreatic cancer.
|
1 year
|
合作者和调查者
调查人员
- 首席研究员:Frank Viborg Mortensen, Prof.、Professor MTK AUh
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 22552255
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