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Liver and the Spleen Stifness in Adult Patients With Gaucher's Disease Using Ultrasound Shear Wave Elastography

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ClinicalTrials.gov Identifier: NCT03896607
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Ziv Neeman, HaEmek Medical Center, Israel

Brief Summary:
The investigated cohort will examine liver and spleen fibrosis in patients with Gaucher Disease(GD) by using Shear Wave Elastography- SWE to evaluation fibrosis of the tissue and to check the correlation of fibrosis with the biomarkers of disease severity.

Condition or disease
Gaucher Disease Liver Fibrosis Spleen; Fibrosis

Detailed Description:

To assess liver and spleen stiffness measurement using Shear Wave Elastography-SWE and evaluate liver and spleen fibrosis in patients with Gaucher Disease. To compare the elastography with the biomarkers that taken at the GD haematology clinic and to check the correlation with severity of liver and spleen fibrosis.

SWE is a safe with diagnostic accuracy regarding the liver (& Spleen) fibrosis. Estimating spleen fibrosis is an innovative approach in liver disease and Gaucher.

The evaluation of fibrosis with this relatively new and safe method could avoid complications and invasive procedure in GD patients .


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study: Shear-Wave Elastography of the Liver and the Spleen in Adult Patients With Gaucher's Disease
Actual Study Start Date : March 30, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 1, 2019





Primary Outcome Measures :
  1. Shear Wave Elastography of liver to asses liver fibrosis in Gaucher disease patients. [ Time Frame: 0-2 hours ]
    Shear wave elastography(SWE),an ultrasound imaging technique that can produce 2D and 3D images and quantified measurements of tissue stiffness noninvasively. SWE obtained from the right liver lobe for staging liver fibrosis according to Metavir Fibrosis Score with sensitivity86%-98% and specificity 90%-93%. SWE well corelated with Metavir Fibrosis Score which is system used to assess the extent of inflammation and fibrosis by histopathological evaluation in a liver biopsy. The biomarkers of disease severity will be correlated to METAVIR score. METAVIR score(F0-F4) ,Fibrosis Level measured by KPa(kiloPascal) using SWE. F0 = Below 5 KPa, No fibrosis. F1=5.0-7.1 KPa, Mild Fibrosis. F2=7.1-8.7 KPa, Significant Fibrosis. F3=8.7-10.4 KPa, Sever Fibrosis. F4=10.4-19 KPa ,Cirrhosis. SWE can differentiate patients with no or minimal (F0 and F1) fibrosis from those with severe fibrosis or cirrhosis (F3 and F4) with no need for biopsy unless there are other factors that need to be considered.


Secondary Outcome Measures :
  1. Shear Wave Elastography of spleen to asses spleen fibrosis in Gaucher disease patients. [ Time Frame: 0-2 hours ]

    Shear wave elastography (SWE), an ultrasound imaging technique that can produce 2D and 3D images and quantified measurements of tissue stiffness noninvasively.

    Participants with Gaucher disease will under go shear wave elastography for spleen.

    Ultrasound Elastography is a non-invasive test which uses the technology of Shear Wave Elastography (SWE) obtained from the spleen for staging tissue fibrosis according to a study, Spleen Elastography was performed in 59 healthy individuals and the mean value measured in KPa (kiloPascal) was 16.6 ± 2.5 kPa, independent of patient age, sex or spleen size.

    above the normal value it is considerd fibrosis of the tisuue of the spleen.



Other Outcome Measures:
  1. Biomarkers of the Gaucher Disease [ Time Frame: Up to 1 month ]

    Gaucher Disease (GD) patients will be referred from the (GD) hematology outpatient clinic, in different patients different biomarker are already taken (as blood test).

    Biochemical abnormalities which might be already taken from patients, for example; blood level of ferritin (unit: ng/mL), angiotensin converting enzyme (unit: kU/L), chitotriosidase (unit: U/L) and polyclonal immunoglobulins (unit: ng/dL) .

    Elevated biomarkers can predict the severity of the disease.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult patient with Gaucher disease.
Criteria

Inclusion Criteria:

  1. Patients with Gaucher disease over the age of 18 years.
  2. Patients able to sign informed consent form.
  3. Women are not pregnant.
  4. Patients who read and understood the contents of the consent form and gave their written consent to participate in the study.

Exclusion Criteria:

  1. Participants under the age of 18.
  2. Pregnant women.
  3. Participants are unable to sign an informed consent form.
  4. Participants with known liver disease not associated with Gaucher disease such as liver cirrhosis, patients with HBV, HBC or liver cirrhosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896607


Contacts
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Contact: Ziv Neeman, MD +972584988466 ziv_ne@clalit.org.il
Contact: Rayiq Wisam Shajrawi, MD +972524234067 rayek_sh@hotmail.com

Locations
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Israel
HaEmek Medical Center Recruiting
Afula, Tsafon, Israel, 1834111
Contact: ziv neeman, MD    +972584988466    ziv_ne@clalit.org.il   
Contact: Rayiq Wisam Shajrawi, MD    +972524234067    rayek_sh@hotmail.com   
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Principal Investigator: ziv neeman, MD haemek medical center

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Responsible Party: Ziv Neeman, Head of Radiology department, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT03896607     History of Changes
Other Study ID Numbers: 0135-18-EMC
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ziv Neeman, HaEmek Medical Center, Israel:
shear wave elastography
Additional relevant MeSH terms:
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Liver Cirrhosis
Gaucher Disease
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Sphingolipidoses
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Lipid Metabolism Disorders