Quantitative Real-time Ultrasound Elastography for Characterisation of Liver Tumors
1 other identifier
observational
196
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 12, 2014
CompletedFirst Posted
Study publicly available on registry
June 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 24, 2015
December 1, 2015
2.2 years
May 12, 2014
December 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
tumor to parenchyma stiffness ratio
at the time of enrollment
Study Arms (1)
Liver tumors
Measurement of tumor stiffness by Shear wave elastography - SWE™
Interventions
Measurement of tumor stiffness by Shear wave elastography - SWE™
Eligibility Criteria
outpatients and inpatients in a tertiary care hsopital
You may qualify if:
- liver tumors detected on US examination of the liver
- compliance to the study protocol
- signed approval for the diagnostic ultrasound with SWE™
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Dubrava
Zagreb, 10040, Croatia
Related Publications (4)
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.
PMID: 19669335BACKGROUNDDavies 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.
PMID: 21385910BACKGROUNDCho 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.
PMID: 20018432BACKGROUNDHeide 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.
PMID: 20652853BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ivica Grgurevic, MD, PhD
University Hospital Dubrava
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
May 12, 2014
First Posted
June 5, 2014
Study Start
September 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
December 24, 2015
Record last verified: 2015-12