Study of Liver Fibrosis Stage Assessment by Fibroblast Activation Protein Imaging in Patients With Biopsy for Suspected or Proven Nonalcoholic Steatohepatitis

NCT06160271 | Not Yet Recruiting Phase 2

• 1 other identifier: 2022PI044
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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 which is cirrhosis, a major cause of liver transplantation. The prevalence of NASH is increasing worldwide, along with that of type 2 diabetes and obesity. Significant liver fibrosis is estimated to affect at least 2.6% of the adult population in France. The prognosis of patients with NASH is directly linked to the stage of liver fibrosis determined by biopsy, and these biopsies must now be repeated to assess the effect of treatments. Hepatic fibrosis is traditionally classified into five stages, from the absence of fibrosis (F0) to severe cirrhosis (F4), and passage from one stage to another is considered to demonstrate significant variation, likely to impact prognosis. However, liver biopsy is painful. It can only analyze a very small proportion of liver volume (1/50,000), whereas the distribution of fibrosis is generally heterogeneous. Above all, biopsy is not devoid of risks, primarily hemorrhage, which can sometimes be severe or even fatal. In line with current recommendations, clinical-biological algorithms, as well as ultrasound elastography or MRI, are used to assess the risk of fibrosis and the value of a liver biopsy. Generally speaking, these tests have the advantage of very good negative predictive values, making it possible to exclude the possibility of significant fibrosis in a large proportion of patients. However, their positive predictive values are weaker, even when these tests are combined. Above all, they do not allow us to follow the evolution of the fibrosis stage over time. This is why liver biopsies remain indispensable for determining the stage and severity of hepatic fibrosis and monitoring its evolution. It is therefore essential to develop more precise, non-invasive methods for accurately assessing the extent of liver fibrosis. This is the objective of the FreSH national cohort, which uses conventional biological techniques and in which our patients will also be included.

Conditions

Non-alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Capture intensity measurement

  Measurement of 68Ga-FAPI-46 uptake intensity, with standardized uptake values in areas centred on the biopsy sites, the reference then being a classification of fibrosis stages determined by centralized biopsy rereading

  1 year

Secondary Outcomes (5)

• Standardized Uptake Value threshold values associated with each of the four fibrosis histological stage groups

  1 year

• Localization of the capture zone with maximum activity

  1 year

• Search, on whole-body images, for 68Ga-FAPI-46 uptake

  1 year

• Intra-class correlation coefficients

  1 year

• Variation in the degree of prediction of the four groups of histological stages of fibrosis

  1 year

Study Arms (1)

TEP 68Ga-FAPI

EXPERIMENTAL

Use of a positron emission tomograph equipped with an X-ray scanner (PET/CT), essential for recording images after injection of a positron-emitting radiopharmaceutical (in this study, 68Ga-FAPI-46).

Drug: PET scan of 68Ga-FAPI

Interventions

PET scan of 68Ga-FAPI DRUG

Use of a positron emission tomograph equipped with an X-ray scanner (PET/CT), essential for recording images after injection of a positron-emitting radiopharmaceutical (in this study, 68Ga-FAPI-46).

TEP 68Ga-FAPI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Chevalier Elodie, MD

CONTACT

+3383153475; e.chevalier@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 9, 2024

Record last verified: 2023-11