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临床试验/NCT06895655
NCT06895655尚未招募不适用

Diffusion Weighted MRI Compared to Ultrasound Elstography in the Assessment of Pancreatic Masses.

Assiut University0 个研究点目标入组 50 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
for shear wave elastography

研究概览

简要总结

To compare transcutaneous ultrasound elstography to Diffusion weighted MRI in differentiating between benign and malignant pancreatic masses.

详细描述

There are many types of pancreatic masses classified based on their nature (benign vs. malignant), type (solid vs. cystic), and histological characteristics such as pancreatic cysts, pseudocysts with pooled prevalence rate of 8%,, pancreatic ductal carcinoma (PDAC) accounts for more than 85%, neuroendocrine tumors (NET) less than 5%, and solid pseudopapillary neoplasms account for approximately 0.9%-2.7% of all exocrine pancreatic neoplasms and 5% of cystic pancreatic neoplasms. Moreover, there are some pancreatic tumorous diseases such as chronic pancreatitis and autoimmune pancreatitis .

Pancreatic cancer has a low 5-year relative survival rate of 9% .Unfortunately, the global incidence of pancreatic ductal adenocarcinoma (PDAC) is increasing by about 1% annually Presently, PDAC is the seventh leading cause of cancer-related mortality in the world, with more than 300,000 deaths reported each year.

Typically, imaging assessment is the initial process in the diagnosis of PDAC. Endoscopic ultrasonography (EUS) and/or endoscopic retrograde pancreatography may be considered as reliable tools with higher diagnostic ability. However, because of the recent trend of reducing patient burden while ensuring safety, less-invasive methods may be preferred for practical management.

Currently, the commonly used imaging examinations for pancreatic lesions include computed tomography (CT) and magnetic resonance imaging (MRI). However, despite tremendous advances in imaging, it is still challenging to accurately characterize some pancreatic lesions based on morphological imaging, such as identifying small lesions and differentiating pancreatic adenocarcinoma and mass-forming pancreatitis which represents about 5-10% of pancreatic mass cases.

Diffusion weighted imaging (DWI) is an MRI method that provides information about the microstructural characteristics of tissues by detecting the random molecular motion of water molecules and generates representative ADC values.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All patients referred to radiology department presented clinically with pancreatic masses and willing to participate in the study.

排除标准

  • •preoperative chemotherapy/radiotherapy cases, pancreatic stenting cases, recurrent cases after previous resection.
  • •patients diagnosed as acute and chronic pancreatitis
  • •other contraindications to MRI such as cardiac pacemaker,claustrophobia.

研究组 & 干预措施

pancreatic mass GROUP

Other

干预措施: MRI and Ultrasound Elastography (Device)

结局指标

主要结局

for shear wave elastography

时间窗: 2 years

increased shear wave speed suggesting malignancy

efficacy diffusion-weighted MRI to differentiate benigen and malignant pancreatic lesions

时间窗: 2 year

a decrease in ADC and hyperintensity signals on DWI suggesting malinant lesion

The quality evaluation for strain elastography : color pattern diagnosis is used for major color tones (blue: hard, red: soft) of tumors

时间窗: 2 years

Strain ratio: high strain ratio indicate that the tumor stiffer than surrounding suggesting malignancy

时间窗: 2 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yousra Ahmed Osman Foley

doctor

Assiut University

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