Quantitative Real-time Ultrasound Elastography for Characterisation of Liver Tumors

Completed

• Conditions: Hepatocellular Carcinoma; Focal Nodular Hyperplasia; Metastases; Cholangiocellular Carcinoma; Haemangioma
• Interventions: Procedure: Shear wave elastography

• Registration Number: NCT02156700
• Lead Sponsor: University Hospital Dubrava

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-06-04
• Study First Posted: 2014-06-05
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-23
• Last Update Posted: 2015-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Liver tumors	Shear wave elastography	Measurement of tumor stiffness by Shear wave elastography - SWE™

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
tumor to parenchyma stiffness ratio	at the time of enrollment	comparison between tumor and surrounding liver parenchyma stiffness as expressed by tumor to liver parenchyma stiffness ratio

Trial Locations

Locations (1)

University Hospital Dubrava; 🇭🇷 Zagreb, Croatia