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NCT06626074 | NOT YET RECRUITING | Non-alcoholic Fatty Liver Disease NAFLD

Exploratory Study of MRI Biomarkers of NASH
Sponsor:

University Hospital, Angers

Brief Summary:

Metabolic steatosis disease (NAFLD) is a rapidly growing disease in the world, particularly in industrialized countries. NAFLD is defined by the presence of fatty liver disease. This is a reversible phenomenon that can be estimated by non-invasive means, such as ultrasound. Non-invasive quantification, on the other hand, requires MRI. Nonalcoholic steatohepatitis (NASH) is the aggressive form of the disease that promotes the accumulation of fibrosis in the liver, which can progress to cirrhosis and its complications. Currently there is no non-invasive biomarker of NASH and the diagnosis is based solely on liver biopsy. There is therefore a need for non-invasive biomarkers of NASH in patients with steatosis to diagnose NASH without the use of liver biopsy.

Condition or disease

Non-alcoholic Fatty Liver Disease NAFLD

Intervention/treatment

Quantitative MRI sequences

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Exploratory Study of MRI Biomarkers of NASH
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2026-12-01
Estimated Study Completion Date : 2026-12-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Patient included in the SNIFF cohort of the Angers hospital where there is a suspicion of NASH requiring a biopsy for which an MRI is requested by a hepatologist as part of the initial assessment of the disease.
  • * Adult patient
  • * Free, informed and express (oral) consent of the patient to participate in the study
Exclusion Criteria
  • * Contraindication to MRI
  • * Time between the establishment of the Steatosis/NASH status and the MRI greater than 3 months
  • * Pregnant, parturient and breastfeeding woman
  • * Person deprived of liberty by judicial or administrative decision
  • * Person under compulsion to psychiatric care
  • * Person subject to a legal protection measure
  • * Person not affiliated or not covered by a social security scheme.
Exploratory Study of MRI Biomarkers of NASH

Location Details

NCT06626074

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How to Participate

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Locations

Not yet recruiting

France,

University Hospital, Angers

Angers, France, 49000