Experimental and Clinical Study of Three-dimensional Magnetic Resonance Elastography to Evaluate Pancreatic Cancer and Interstitial Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Analyzing the measurement accuracy of MRE.
研究概览
简要总结
Pancreatic ductal adenocarcinoma (PDAC) accounts for 85-95% of pancreatic cancer and is one of the deadliest tumors in the world, with a survival rate of less than 8%, and identifying key prognostic or predictive factors facilitates risk stratification and prospective assessment in clinical trials. The extracellular matrix (ECM) surrounding PDAC often exhibits a large number of interstitial fibrosis, which is closely related to the formation, development and metastasis of PDAC. High order three-dimensional MR elastography (3D-MRE) allows non-invasive measurements of sheer stiffness in normal pancreas and pancreatic lesions. However, there are no reports about the application of MRE imaging biomarkers to predict the prognosis of PDAC at home and abroad.
详细描述
Pancreatic ductal adenocarcinoma (PDAC) accounts for 85-95% of pancreatic cancer and is one of the deadliest tumors in the world, with a survival rate of less than 8%, and identifying key prognostic or predictive factors facilitates risk stratification and prospective assessment in clinical trials.
The extracellular matrix (ECM) surrounding PDAC often exhibits a large number of interstitial fibrosis, which is closely related to the formation, development and metastasis of PDAC. Although interstitial composition is considered a double-edged sword, influencing cancer biological progression and modification in multiple complex ways, experimental studies consistently demonstrate that hardening of ECM in PDAC accelerates PDAC progression and is significantly associated with shorter survival. If investigators can noninvasively detect the mechanical properties (hardness) of human PDAC before treatment, it will be helpful to describe the biological characteristics of tumors, predict the prognosis of patients, and choose the right clinical treatment decision.
High order three-dimensional MR elastography (3D-MRE) allows non-invasive measurements of sheer stiffness in normal pancreas and pancreatic lesions. However, there are no reports about the application of MRE imaging biomarkers to predict the prognosis of PDAC at home and abroad.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •granting of written informed consent
- •age ≥18 years
- •no history of extrapancreatic malignancy
- •no preoperative biliary drainage
- •definitive histologic evidence of PDAC in excisional biopsy
- •with no less than three months of postoperative mortality or six months of follow- up
排除标准
- •inability to re-review of tissue specimens
- •unacceptable estimates of MRE parameters, specifically invalid wave data during postprocessing, inconsistent breath-holdings, intolerable pain, and MRE hardware disconnection
- •tumor diameters <1.0 cm
- •withdrawal/dropout during follow-up
研究组 & 干预措施
Plan to include patients with resectable pancreatic cancer 150
Investigators anticipate that 150 resectable pancreatic cancer participants are enrolled in this group and all participants undego magnetic resonance imaging.
干预措施: magnetic resonance imaging (Diagnostic Test)
Plan to include patients with unresectable pancreatic cancer 50
Investigators anticipate that 50 unresectable pancreatic cancer participants are enrolled in this group and all participants undego magnetic resonance imaging.
干预措施: magnetic resonance imaging (Diagnostic Test)
结局指标
主要结局
Analyzing the measurement accuracy of MRE.
时间窗: 9 months
The hardness was measured by a hardness tester during the operation, and the mechanical parameters were measured by atomic force microscopy of the in vitro specimen. The measurement accuracy of MRE was analyzed by comparing the hardness tester and atomic force microscope results.
Radiological assessment of tumor stiffness.
时间窗: 9 months
A self-written script program in MATLAB is used to read and analyze mechanical group diagrams and waveform diagrams in three directions of x, y, and z, and a region of interest (ROI) delineation function is embedded.After drawing the ROI, an Excel file containing the corresponding values is automatically generated, and the average values of various mechanical parameters are calculated, including shear modulus (\|G\*\|, SS), storage modulus (G', SM), loss modulus (G'', LM) and damping ratio (ӡ, DR).
Evaluation of tumor response to chemotherapy.
时间窗: 12 months
RECIST criteria (version 1.1) were used to objectively evaluate the response to chemotherapy.
次要结局
未报告次要终点
研究者
Yu Shi
Associate Professor
Shengjing Hospital