HEFITEP (Phase II)

Investigator physician: Dr Elodie CHEVALIER

Pilot study to evaluate the stage of liver fibrosis using PET imaging of fibroblast activation protein (⁶⁸Ga-FAPI-46 PET/CT) in patients who have undergone biopsy for suspected or confirmed non-alcoholic steatohepatitis (NASH)

Metabolic dysfunction-associated Steatotic Liver Disease

This is a phase 2, non-randomized, multicenter, controlled, cross-sectional pilot study evaluating diagnostic performance.
The HEFITEP study will evaluate for the first time the discriminatory power of ⁶⁸Ga-FAPI-46 PET/CT for grading liver fibrosis, with reference to centrally analyzed liver biopsy, in patients who have undergone biopsy for suspected or confirmed non-alcoholic steatohepatitis (NASH).
The main objective of the study is to demonstrate that the intensity of ⁶⁸Ga-FAPI-46 uptake, measured by PET/CT at biopsied liver sites, differs according to four fibrosis groups, defined on the basis of biopsy sample analyses (stage 4: cirrhosis, stage 3: fibrous septa, stage 2: portal and perisinusoidal fibrosis, and stage <2: perisinusoidal or periportal fibrosis, or no fibrosis).

Diagnostic: ⁶⁸Ga-FAPI-46
Study status: Recruiting
Clinical Trial number: NCT06160271
Funding: PHRC-I (GIRCI-Est)