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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 January 2016 |
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Main ID: |
NCT02156700 |
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Date of registration:
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12/05/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Quantitative Real-time Ultrasound Elastography for Characterisation of Liver Tumors
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Scientific title:
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Quantitative Real-time Ultrasound Elastography (Shear Wave Elastography - SWE™) for Characterisation of Liver Tumors |
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Date of first enrolment:
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September 2013 |
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Target sample size:
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196 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02156700 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Cross-Sectional
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Phase:
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N/A
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Countries of recruitment
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Croatia
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Contacts
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Name:
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Ivica Grgurevic, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Dubrava |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Focal Nodular Hyperplasia
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Haemangioma
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Hepatocellular Carcinoma
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Cholangiocellular Carcinoma
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Metastases
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Intervention(s)
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Procedure: Shear wave elastography
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Primary Outcome(s)
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Tumor stiffness
[Time Frame: at the time of enrollment]
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Secondary Outcome(s)
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tumor to parenchyma stiffness ratio
[Time Frame: at the time of enrollment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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