Fibroscan® Medical Device, Assessment for Non Invasive Diagnosis of Liver Steatosis
TRANSTEATOSE
1 other identifier
interventional
85
1 country
1
Brief Summary
Hypothesis of this study is the existence of a relation between parameters measured by FibroScan® FS 502 according to our non invasive method and liver steatosis condition. This proof of concept validation is made up of two steps:
- Step 1: feasibility study of the method on 10 healthy volunteers
- Step 2: diagnosis study on 50 healthy volunteers (25 between 18-30 years-old and 25 between 40-65 years-old) and on 25 patients whom cares including an liver biopsy et whom the histological answer is clean steatosis (NAFLD). Experimental procedures consist in:
- Fibroscan measure, preceded by tracking ultrasonography.
- liver MRI (for substudy about MRI comparison, in step 2)
- a blood test for biological assessment of liver functions
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2013
Typical duration for not_applicable
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
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
October 14, 2015
CompletedOctober 16, 2015
October 1, 2015
2.5 years
September 30, 2015
October 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Viscosity in Pa.s
Digital files recorded by medical device will be mathematically processed for extracting elasticity G' and viscosity G'' curves in accordance with the frequency. These curves use to identify the 5 parameters: mu(M), eta(M), alpha, mu(V), eta(V); which describe visco-elasticity variations with frequency thanks to an Matlab algorithm
One day
Elasticity in kPa
Digital files recorded by medical device will be mathematically processed for extracting elasticity G' and viscosity G'' curves in accordance with the frequency. These curves use to identify the 5 parameters: mu(M), eta(M), alpha, mu(V), eta(V); which describe visco-elasticity variations with frequency thanks to an Matlab algorithm
One day
Secondary Outcomes (3)
Reproductibility quantification in arbitrary unit
through study completion, an average of 2 years
Age in years
through study completion, an average of 2 years
Liver signal intensity changes in decibel
through study completion, an average of 2 years
Study Arms (1)
Fibroscan exam
EXPERIMENTALStep 1: feasibility study of the method on 10 healthy volunteers Step 2: diagnosis study on 50 healthy volunteers (25 between 18-30 years-old and 25 between 40-65 years-old) and on 25 patients whom cares including an hepatic biopsy et whom the histological answer is clean steatosis (NAFLD). Experimental procedures consist in: * Fibroscan measure, preceded by tracking sonography. * liver MRI (for substudy about MRI comparison, in step 2) * a blood test for biological assessment of liver functions
Interventions
Three series oh independent measures Measure done with Fibroscan will be preceded by tracking ultrasonography.
Blood test for biological assessment of liver function
Eligibility Criteria
You may qualify if:
- Healthy subjects - Steps 1 and 2
- Age between 18 and 65 years old (2 age groups for step 2 : 18-30 et 40-65 years-old)
- Written inform consent form signed
- Affiliated to medical insurance
- Alcohol consumption d'alcool \< 20g/j for women, \<30g/j for men
- Patients with liver steatosis - Step 2
- More than 18 years -old
- Written inform consent form signed
- Affiliated to medical insurance
- Patients with clean steatosis confirmed by histological results of a liver biopsy done the previous month
- Alcohol consumption d'alcool \< 20g/j for women, \<30g/j for men
You may not qualify if:
- Healthy subjects - Step 1
- Exposure to chemical poisons (solvents, paints, drugs) in the previous 4 weeks
- Pregnant women, lactating women, and women in age for procreation and without reliable contraception
- Presence of ascites
- Person under guardianship
- Healthy subjects - Step 2
- Exposure to chemical poisons (solvents, paints, drugs) in the previous 4 weeks
- Pregnant women, lactating women, and women in age for procreation and without reliable contraception
- Contraindication to MRI
- Presence of ascites
- Person under guardianship
- Healthy subjects - Steps 1 and 2
- Presence of liver tumor or ascites (diagnosed with MRI or ultrasonography)
- Abnormal liver function tests (increase of transaminases, gammaGT)
- Patients with liver steatosis - Step 2
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Tourslead
- Echosenscollaborator
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
Study Sites (1)
University Hospital of Tours
Tours, 37044, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frederic PATAT, MD, PhD
CHRU TOURS
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2015
First Posted
October 14, 2015
Study Start
April 1, 2013
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
October 16, 2015
Record last verified: 2015-10