Functional Magnetic Resonance Imaging of Pancreatic Cancer: a Feasibility and Reproducibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Reproducibility of DCE, T2* and DWI MRI in pancreatic cancer.
研究概览
简要总结
Novel predictive markers are needed to determine treatment efficacy in pancreatic cancer at an early stage. Preferably, these markers could be determined non-invasively and provide insight into the biology of pancreatic cancer. Several MR techniques can serve for this purpose. However, optimalisation of these techniques is needed and their reproducibility should be assessed.
详细描述
Background of the study:
Novel predictive markers are needed to determine treatment efficacy in pancreatic cancer at an early stage. Preferably, these markers could be determined non-invasively and provide insight into the biology of pancreatic cancer. Several MR techniques can serve for this purpose. However, optimalisation of these techniques is needed and their reproducibility should be assessed.
Objective of the study:
To optimize DCE-MRI, T2* MRI and DWI in pancreatic cancer at 3T and investigate its reproducibility.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients with pancreatic tumors, with histological or cytological proof of adenocarcinoma or a high suspicion on CT imaging.
- •Any tumor with a size ≥ 1cm
- •WHO-performance score 0-2
- •Written informed consent
排除标准
- •Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol.
- •Contra-indications for MR scanning, including patients with a pacemaker, cochlear implant or neurostimulator; patients with non-MR compatible metallic implants in their eye, spine, thorax or abdomen; or an aneurysm clip in their brain; patients with severe claustrophobia.
- •Renal failure (GFR < 30 ml/min) hampering safe administration of Gadolinium containing MR contrast agent.
- •For the reproducibility part of the protocol: surgery, radiation and/or chemotherapy foreseen within the timeframe needed for MRI scanning.
研究组 & 干预措施
Optimization
For optimization of the protocol patients will undergo one DCE-MRI (Gadobutrol), T2* MRI and DWI MRI scan.
干预措施: Gadobutrol (Drug)
Reproducibility
For determination of the reproducibility patients will undergo two DCE-MRI (Gadobutrol), T2* MRI and DWI MRI scans within one week.
干预措施: Gadobutrol (Drug)
结局指标
主要结局
Reproducibility of DCE, T2* and DWI MRI in pancreatic cancer.
时间窗: Within 1 week
To assess reproducibility, 15 patients will undergo the MR measurement protocol twice within one week before start of any treatment. Reproducibility of; DWI: mean ADC of the whole tumor. DCE: mean Ktrans of the whole tumor. T2\*: average value of the whole tumor.
次要结局
- Compare in vivo measurements of tumor vascularity, hypoxia and stroma using DCE-MRI, T2* MRI and DWI with immunohistochemically determined markers of vascularity, hypoxia and stroma in pancreatic tumor tissue(Within 1 week)
- To explore the relation between in vivo measurements of tumor vascularity, hypoxia and stroma using DCE-MRI, T2* MRI and DWI and treatment outcome.(1 year)
研究者
H.W.M. van Laarhoven
M.D., Ph.D.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)