HaemangiomaNCT02156700
Quantitative Real-time Ultrasound Elastography for Characterisation of Liver Tumors
An observational study of Haemangioma and Metastases, run by University Hospital Dubrava at 1 site in Croatia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemangioma, Metastases, Cholangiocellular Carcinoma
- What is being tested?
- Shear wave elastography
- Type of treatment
- Surgery or procedure
- How many people
- 196 participants
- Where
- 1 siteCroatia
- Study dates
- Sep 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: outpatients and inpatients in a tertiary care hsopital
Who may be able to join
- liver tumors detected on US examination of the liver
- compliance to the study protocol
- signed approval for the diagnostic ultrasound with SWE™
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative Real-time Ultrasound Elastography (Shear Wave Elastography - SWE™) for Characterisation of Liver Tumors
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.
- Conditions
- Haemangioma, Metastases, Cholangiocellular Carcinoma, Hepatocellular Carcinoma, Focal Nodular Hyperplasia
- Being tested
- Shear wave elastography
- Keywords
- shear wave elastography, haemangiomas, metastases, hepatocellular carcinoma, focal nodular hyperplasia, cholangiocellular carcinoma
- Medical subject headings
- Hemangioma, Capillary, Neoplasm Metastasis, Cholangiocarcinoma, Carcinoma, Hepatocellular, Focal Nodular Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear wave elastographyProcedure or surgery
Also called Shear wave elastography - SWE™
Measurement of tumor stiffness by Shear wave elastography - SWE™
| Study group | Role | What they receive |
|---|---|---|
| Liver tumors | Measurement of tumor stiffness by Shear wave elastography - SWE™ Receives: Procedure: Shear wave elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor stiffness
tumor stiffness expressed in kPa, measured by ShearWave ™ Elastography (SWE™) Aixplorer® ultrasound machine from SuperSonic Imagine, Aix-en-Provence, France
Measured: at the time of enrollment
Secondary outcomes (1)
tumor to parenchyma stiffness ratio
comparison between tumor and surrounding liver parenchyma stiffness as expressed by tumor to liver parenchyma stiffness ratio
Measured: at the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HaemangiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivica Grgurevic, MD, University Hospital Dubrava
- Investigators
- Ivica Grgurevic, MD, PhD, Principal investigator, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156700
- Sponsor's protocol ID
- KBD-IG1
- Status last verified
- Dec 2015
- First submitted
- 12 May 2014
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19669335Davies 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.
PubMed 21385910Cho 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.
PubMed 20018432Heide 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.
PubMed 20652853
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Real-time Ultrasound Elastography (Shear Wave Elastography - SWE™) for Characterisation of Liver Tumors
- ClinicalTrials.gov ID
- NCT02156700
- Acronym / sponsor ID
- KBD-IG1
- Conditions
- Haemangioma, Metastases, Cholangiocellular Carcinoma, Hepatocellular Carcinoma, Focal Nodular Hyperplasia
- Keywords
- shear wave elastography, haemangiomas, metastases, hepatocellular carcinoma, focal nodular hyperplasia, cholangiocellular carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver tumors | – | Procedure: Shear wave elastographyMeasurement of tumor stiffness by Shear wave elastography - SWE™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatients and inpatients in a tertiary care hsopital
Key inclusion criteria (3 listed)
- liver tumors detected on US examination of the liver
- compliance to the study protocol
- signed approval for the diagnostic ultrasound with SWE™
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shear wave elastographyAlso: Shear wave elastography - SWE™Measurement of tumor stiffness by Shear wave elastography - SWE™ | Procedure or surgery | Liver tumors |
Primary outcome
Tumor stiffness
Time frame: 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
1 secondary outcome
tumor to parenchyma stiffness ratio
Time frame: at the time of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
- Background: PubMed 19669335Masuzaki 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.
- Background: PubMed 21385910Davies 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.
- Background: PubMed 20018432Cho 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.
- Background: PubMed 20652853Heide 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivica Grgurevic, MD, PhD principal investigator
University Hospital Dubrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemangioma and Metastases, run by University Hospital Dubrava at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor stiffness (time frame: at the time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02156700, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2015.