Informations générales (source: ClinicalTrials.gov)
Fibroscan® Medical Device, Assessment for Non Invasive Diagnosis of Liver Steatosis (TRANSTEATOSE)
Interventional
N/A
University Hospital, Tours (Voir sur ClinicalTrials)
avril 2013
octobre 2015
29 juin 2024
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
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| University Hospital of Tours - 37044 - Tours - France | Frederic PATAT, MD, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- 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
- 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
- liver tumor
- Serology anti VHC+ or Ag HBs+
- Infection by HIV
- Auto-immun hepatitis
- Genetic hemochromatosis, Wilson disease, lake of alpha-1-antitrypsin
- Fibrosis or liver cirrhosis at biopsy
- Person under guardianship