Quantitative Real-time Ultrasound Elastography for Characterisation of Liver Tumors
Conditions
Haemangioma - Metastases - Cholangiocarcinoma - Hepatocellular Carcinoma
Conditions: official terms
Carcinoma, Hepatocellular - Cholangiocarcinoma - Hemangioma
Conditions: Keywords
shear wave elastography, haemangiomas, metastases, hepatocellular carcinoma
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Cross-Sectional
Intervention
Name: Shear wave elastography
Type: Procedure
Overall Status
Recruiting
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 three groups: 1) hemangiomas presenting the most common benign liver tumors; 2) metastases and cholangiocarcinomas presenting malignant tumors mostly appearing in otherwise healthy liver, and 3) hepatocellular carcinomas which will be evaluated separately because they occur mostly in cirrhotic liver which can potentially influence elastographic measurements therefore querying the appropriateness of comparison between tumors in healthy and cirrhotic liver. 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. Enrolled patients will undergo transabdominal ultrasonography and SWE™ examination. The tumor stiffness will be measured five times for each tumor. Mean tumor stiffness for each group will be calculated as well as a cut-off value for the differentiation of benign and malignant tumors. The clinical value of the method will be appraised based on specificity, sensitivity, positive and negative predictive values.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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, metastasis, cholangiocellular carcinoma (CCC) or hepatocellular carcinoma (HCC) in the proximity of liver capsule (less than 1 cm from the liver surface)

- haemangioma, metastasis, CCC or HCC deep in the lever parenchyma (more than 7 cm away from the surface)

- liver tumors other than haemangioma, 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
Location
University Hospital Dubrava
Zagreb, Croatia
Status: Recruiting
Contact: Tomislav Bokun, MD - 00385981931020 - tbokun@gmail.com
Start Date
September 2013
Sponsors
University Hospital Dubrava
Source
University Hospital Dubrava
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page