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临床试验/NCT01317836
NCT01317836已完成不适用

PET-CT in Diagnosis of Pancreatic Cystic Neoplasms

Turku University Hospital1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Predictive Value of PET/CT imaging for Identifying Malignant and Benign Pancreatic Cystic Lesions

研究概览

简要总结

Preoperative diagnosis of pancreatic cystic lesions remains a difficult problem in clinical practice. At present, the treatment planning in pancreatic cystic neoplasms is significantly restricted by the limited preoperative diagnosis. Ultrasonography (US), multidetector computed tomography (MDCT) and magnetic resonance imaging (MRI) are the conventional modalities in imaging of pancreatic cystic neoplasms, but by these methods the diagnostic accuracy still remains compromised. Furthermore, recently encouraging results have been obtained in pancreatic cystic neoplasms using 18F-fluoro-2-deoxyglucose positron emission tomography (18F-FDG-PET) The aim of the current project is to evaluate the possibility to enhance the diagnostic accuracy by using the combined 18F-FDG-PET-CT imaging in patients with pancreatic cystic neoplasms by combining PET-CT with MRI and MDCT.

详细描述

Today, in clinical practice the diagnosis pancreatic cystic neoplasms are based on MDCT, MRI and ERCP followed by surgical exploration. The information gained by conventional imaging modalities is restricted to the morphological details, which usually is insufficient for the definitive staging of the pancreatic cystic neoplasms. Based on these previous studies, it seems that PET especially combined with CT modality could improve the diagnostic accuracy of the pancreatic cystic lesions.

So far, there are only few cases published concerning the role of 18F-FDG-PET-CT in the differential diagnosis of cystic pancreatic lesions. Therefore, more studies are needed to determine the role of combined 18F-FDG-PET-CT in the diagnosis of pancreatic cystic lesions.

The aim of the current project is to evaluate the possibility to enhance the diagnostic accuracy by using the combined 18F-FDG-PET-CT imaging in patients with pancreatic cystic neoplasms by combining PET-CT with MRI and MDCT.

The study consists of 20-30 patients with pancreatic cystic neoplasms. The patients enrolled in the study will be imaged by MDCT, MRI combined with magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP) and 18F-FDG-PET-CT followed by surgery or follow-up. The data will be collected between 2011 and 2013.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • suspicion of pancreatic cystic neoplasm using US, MDCT, MRI and/or ERCP
  • laparotomy planned because of the lesion
  • signed informed consent

排除标准

  • 未提供

结局指标

主要结局

Predictive Value of PET/CT imaging for Identifying Malignant and Benign Pancreatic Cystic Lesions

时间窗: 1 mo

To determine sensitivities, specificities, accuracy and positive/negative predictive values of PET/CT imaging for differentiating malignant and benign cystic lesions in patients who are to undergo surgical resection.

次要结局

  • To compare PET/CT to ERCP, MDCT and MRI-MRCP(1 mo)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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