Quantitative Real-time Ultrasound Elastography for Characterisation of Liver Tumors

Study Overview
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Brief Summary
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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.

Official Title
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Quantitative Real-time Ultrasound Elastography (Shear Wave Elastography - SWE™) for Characterisation of Liver Tumors

Conditions
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Haemangioma, Metastases, Cholangiocellular Carcinoma, Hepatocellular Carcinoma, Focal Nodular Hyperplasia

Intervention / Treatment
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* Procedure: Shear wave elastography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: liver tumors detected on US examination of the liver compliance to the study protocol signed approval for the diagnostic ultrasound with SWE™ Exclusion Criteria: haemangioma, focal nodular hyperplasia (FNH), metastasis, cholangiocellular carcinoma (CCC) or hepatocellular carcinoma (HCC) in the proximity of liver capsule (less than 1 cm from the liver surface) haemangioma, FNH, metastasis, CCC or HCC deep in the lever parenchyma (more than 7 cm away from the surface) liver tumors other than haemangioma, FNH, metastasis, CCC and HCC severe hepatitis defined by alanine aminotransferase (ALT) values > 5 x upper limit of normal (ULN) obstructive jaundice congestive heart failure pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liver tumors<br>Measurement of tumor stiffness by Shear wave elastography - SWE™ | Procedure: Shear wave elastography<br>* Measurement of tumor stiffness by Shear wave elastography - SWE™<br>* Other names: Shear wave elastography - SWE™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor stiffness | tumor stiffness expressed in kPa, measured by ShearWave ™ Elastography (SWE™) Aixplorer® ultrasound machine from SuperSonic Imagine, Aix-en-Provence, France | at the time of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor to parenchyma stiffness ratio | comparison between tumor and surrounding liver parenchyma stiffness as expressed by tumor to liver parenchyma stiffness ratio | at the time of enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shear wave elastography, haemangiomas, metastases, hepatocellular carcinoma, focal nodular hyperplasia, cholangiocellular carcinoma