Active clinical trials for "Focal Nodular Hyperplasia"

Focal nodular hyperplasia (FNH) in liver is the second common benign hepatic tumor. It usually shows hypervascular mass on imaging studies and it is not easy to differentiate with other hypervascular malignant tumor. For diagnosis of FNH, contrast-enhanced ultrasonography (US) has been used to detect 'spoke-wheel sign', which can be typically seen in FNH. However, temporal window of vascular phase using contrast-enhanced US (CEUS) is very short (about 10 sec) and coordination of patient's respiration during US exam is absolutely needed. Thus, the investigators will use Superb-Microvascular imaging (SMI, Toshiba, Japan) for detection of 'spoke-wheel sign' in patients with proven FNH, which enable to detect slow micro vascular flow without using CEUS. First, to compare the detection rate of 'spoke-wheel sign' between CEUS using sonazoid (Perfluorobutane, GE healthcare) and SMI. Second, to compare the accuracy of size measurement between gray-scale US and SMI (reference standard: CEUS using sonazoid.)

Shear Wave Elastography (SWE™) is a quantitative elastography method for measuring tissue stiffness. The difference in stiffness between benign and malignant tumors has been demonstrated by other elastography methods (acoustic radiation force impulse imaging, transient elastography and/or magnetic resonance elastography). The investigators hypothesized that benign liver tumors are softer than malignant liver tumors measured by SWE™, allowing differentiation between the two by tumor stiffness expressed in kilopascal (kPa). In this study benign and malignant liver tumors will be evaluated in five groups: 1) hemangioma and 2) focal nodular hyperplasia (FNH) representing the most common benign liver tumors; 3) metastases and 4) cholangiocarcinoma (CCC), both presenting malignant tumors mostly appearing in otherwise healthy liver, and 5) hepatocellular carcinoma (HCC) mostly occurring in cirrhotic liver, which can potentially influence elastographic measurements therefore querying the appropriateness of comparison between tumors in healthy and cirrhotic liver. Enrolled patients will undergo transabdominal ultrasonography and SWE™ examination. The tumor stiffness will be measured five times for each tumor. Additionally, surrounding liver parenchyma stiffness will be measured. The nature of the liver tumor will be defined through a standard diagnostic workup according to current guidelines, including contrast enhanced multi-slice CT, MRI and/or cytology/histology, as applicable. In the final analysis the mean tumor stiffness and tumor-parenchyma ratio will be calculated for each group as well as for benign and malignant tumors separately, and cut-off values for the differentiation of various groups will be derived. The clinical value of the method will be appraised based on specificity, sensitivity, positive and negative predictive values, and AUC.

The aim of the study is to assess the value of contrast enhanced ultrasound in the evaluation of de novo focal liver lesions in clinical practice, in a prospective multi-center design.