Status:
NOT_YET_RECRUITING
Study of Liver Fibrosis Stage Assessment by Fibroblast Activation Protein Imaging in Patients With Biopsy for Suspected or Proven Nonalcoholic Steatohepatitis
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Non-alcoholic Steatohepatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Non-alcoholic fatty liver disease (NAFLD), estimated to be 17% prevalent in France, can lead to non-alcoholic steatohepatitis (NASH), which in turn can progress to fibrosis, the ultimate stage of whic...
Detailed Description
Non-alcoholic fatty liver disease (NAFLD), estimated to be 17% prevalent in France, can lead to non-alcoholic steatohepatitis (NASH), which in turn can progress to fibrosis, the ultimate stage of whic...
Eligibility Criteria
Inclusion
- Individuals with recent liver biopsy for suspected or confirmed NASH
- Individuals of legal age, who have received full information on the organization of the research and have signed an informed consent form.
- Person, affiliated to a social security scheme or beneficiary of such a scheme.
- Person who has undergone a preliminary clinical examination appropriate to the research.
- Histological stage of fibrosis obtained at biopsy in accordance with the planned numbers (an equivalent number of patients with histological stages \>2 and ≤ 2 must be recruited in each center, and a number of at least 16 patients must be included by all centers in each of the 4 groups of histological stages of fibrosis).
Exclusion
- Known hypersensitivity to 68Ga-FAPI-46 or to any of the excipients or components of the radiopharmaceutical.
- Infection with HCV/HBV.
- Decompensated cirrhosis (ascites, hepatic insufficiency, hepatorenal syndrome, etc.).
- Known hepatocellular carcinoma.
- Steatogenic treatment (corticosteroid, Tamoxifen, Amiodarone, Methotrexate).
- Excessive alcohol consumption in the last 5 years (\>210 g/week in men, \>140 g/week in women).
- Clinically unstable state not suitable for 68Ga-FAPI-46 PET/CT scan.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06160271
Start Date
September 1 2024
End Date
June 1 2027
Last Update
February 9 2024
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