跳至主要内容
临床试验/NCT05977777
NCT05977777招募中不适用

Characterization of Pancreatic Lesions Using Dynamic Contrast-enhanced Ultrasound

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年11月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
diagnostic agreement between contrast-enhanced ultrasound and histology

研究概览

简要总结

The characterization of pancreatic lesions is one of the fundamental steps in the management of pancreatic neoplastic diseases. In terms of a subjective assessment of vascular enhancement in the various examination stages, the use of contrast-enhanced ultrasonography (CEUS) in the study of pancreatic neoplastic disease has been thoroughly investigated. Technology advancements have enabled the development of software that can perform an objective study of the parameters of vascular enhancement and their variations during dynamic CEUS (DCEUS). Currently, the paucity of data regarding the characterization of pancreatic lesions trough DCEUS limit the definition of its role in pancreatic disease. The main purpose of this study is to employ the knowledge in this field trough the characterization of focal pancreatic lesions using DCEUS.

详细描述

Pancreatic cancer is currently one of the most prevalent malignant neoplasms, characterized by an increasing prevalence and a high mortality and lethality rate. It is the seventh most common malignant tumor in the general population, the fourth most deadly in both sexes, with a 5-year survival rate of approximately 9%. The lack of an early diagnostic tool and the absence of effective treatments for advanced-stage disease are the major contributors to this poor prognosis.

The diagnosis of pancreatic cancer is based on the results of multiple examinations, including various imaging modalities, until the histological diagnosis is obtained through biopsy. Transabdominal ultrasound (US) computed tomography (CT), magnetic resonance imaging (MRI), and endoscopic ultrasound (EUS) are performed to detect and stage pancreas cancer in resectable, borderline, locally advanced and metastatic. Hence, the differential diagnosis and characterization of solid pancreatic tumors represent a crucial step in identifying a suitable therapeutic strategy.

Transabdominal US is frequently used as a first-line diagnostic tool for patients with suspected pancreatic diseases. The main limitation of transabdominal US is the low accuracy in the differential diagnosis between malignant and benign solid lesions, and, considering malignant lesions, between the different pancreatic tumors (adenocarcinomas, neuroendocrine tumors, carcinosarcomas, lymphomas) since all these masses appear as hypoechoic formations.

The introduction of ultrasound contrast agent (UCA) has significantly improved the diagnostic abilities of conventional ultrasound and contrast enhanced ultrasound (CEUS) has been widely implemented in clinical practice because of the enormous quantity of information it provides, along with its low cost, reproducibility, minimal invasiveness, and safety of the UCA. In the detection of pancreatic cancer, contrast enhanced ultrasound (CEUS) achieve a sensitivity and specificity of 92% and 76%, respectively. The European Federation for Ultrasound in Medicine and Biology (EFSUMB) has recently defined the importance of contrast-enhanced ultrasonography (CEUS) in the diagnosis of pancreatic disease, supporting its use to characterize B-mode-identified pancreatic solid lesions.

Despite its numerous advantages, one of the most significant limitations of CEUS is the subjective evaluation of contrast enhancement related behavior of tissues examined. In recent years, one of the methods explored to overcome this limitation has been the Dynamic CEUS (DCEUS) which allow the quantitative analysis of UCA-kinetics in a specific region of interest (ROI). It consists of measuring the average intensity of a ROI following a bolus injection of UCA and generating a time-intensity curve (TIC). Then, multiple parameters are derived from the TIC to quantitatively characterize the different stages of the wash-in and wash-out phases. These parameters can be divided into three categories: time parameters, intensity parameters and area under the curve (AUC).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

diagnostic agreement between contrast-enhanced ultrasound and histology

时间窗: within 3 months from enrollement

to quantify peak enhancement intensity in Arbitray Units AU (measured by analysing D-CEUS time-intensity curves) in patients with pancreatic lesions, stratified according to the histologic exam of pancreatic lesions

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

Zocco Maria Assunta

Prof

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (2)

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