Quantitative Real-time Ultrasound Elastography for Characterisation of Liver Tumors

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02156700
• Other study ID #: KBD-IG1
• Status: Completed
• Phase: N/A
• First received: May 12, 2014
• Last updated: December 23, 2015
• Start date: September 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University Hospital Dubrava
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Cholangiocellular Carcinoma
• Focal Nodular Hyperplasia
• Haemangioma
• Hemangioma
• Hepatocellular Carcinoma
• Hyperplasia
• Metastases

Intervention

Procedure:
• Shear wave elastography
Measurement of tumor stiffness by Shear wave elastography - SWE™

Locations

Country	Name	City	State
Croatia	University Hospital Dubrava	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Dubrava

Country where clinical trial is conducted

Croatia, 

References & Publications (4)

Cho SH, Lee JY, Han JK, Choi BI. Acoustic radiation force impulse elastography for the evaluation of focal solid hepatic lesions: preliminary findings. Ultrasound Med Biol. 2010 Feb;36(2):202-8. doi: 10.1016/j.ultrasmedbio.2009.10.009. Epub 2009 Dec 16. — View Citation

Davies G, Koenen M. Acoustic radiation force impulse elastography in distinguishing hepatic haemangiomata from metastases: preliminary observations. Br J Radiol. 2011 Oct;84(1006):939-43. doi: 10.1259/bjr/97637841. Epub 2011 Mar 8. — View Citation

Heide R, Strobel D, Bernatik T, Goertz RS. Characterization of focal liver lesions (FLL) with acoustic radiation force impulse (ARFI) elastometry. Ultraschall Med. 2010 Aug;31(4):405-9. doi: 10.1055/s-0029-1245565. Epub 2010 Jul 22. — View Citation

Masuzaki R, Tateishi R, Yoshida H, Sato T, Ohki T, Goto T, Yoshida H, Sato S, Sugioka Y, Ikeda H, Shiina S, Kawabe T, Omata M. Assessing liver tumor stiffness by transient elastography. Hepatol Int. 2007 Sep;1(3):394-7. doi: 10.1007/s12072-007-9012-7. Epub 2007 Jul 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No