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Quantitative Real-time Ultrasound Elastography for Characterisation of Liver Tumors

NCT ID: NCT02156700

Last Updated: 2015-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

196 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-12-31

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.

Detailed Description

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Conditions

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Haemangioma Metastases Cholangiocellular Carcinoma Hepatocellular Carcinoma Focal Nodular Hyperplasia

Keywords

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shear wave elastography haemangiomas metastases hepatocellular carcinoma focal nodular hyperplasia cholangiocellular carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Liver tumors

Measurement of tumor stiffness by Shear wave elastography - SWE™

Shear wave elastography

Intervention Type PROCEDURE

Measurement of tumor stiffness by Shear wave elastography - SWE™

Interventions

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Shear wave elastography

Measurement of tumor stiffness by Shear wave elastography - SWE™

Intervention Type PROCEDURE

Other Intervention Names

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Shear wave elastography - SWE™

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Dubrava

OTHER

Sponsor Role lead

Responsible Party

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Ivica Grgurevic, MD

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ivica Grgurevic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Dubrava

Locations

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University Hospital Dubrava

Zagreb, , Croatia

Site Status

Countries

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Croatia

References

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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.

Reference Type BACKGROUND
PMID: 19669335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21385910 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20018432 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20652853 (View on PubMed)

Other Identifiers

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KBD-IG1

Identifier Type: -

Identifier Source: org_study_id