Authorised Therapeutic exploratory (Phase II) non-alcoholic hepatic steatosisalcoholic hepatic steatosis

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

EU CTIS ID: 2024-511788-27-01

What this study is testing

Démontrer que l’intensité de la captation de 68Ga-FAPI-46, mesurée en TEP/TDM au niveau de sites hépatiques biopsiés, est différente en fonction de quatre groupes de fibrose, définis à partir des analyses des prélèvements biopsiques (stade 4 : cirrhose, stade 3 : septa fibreux, stade 2 : fibrose portale et périsinusoïdale, et stade <2 : fibrose périsinusoïdale ou périportale, ou fibrose absente (Kleiner, 2005)).

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Individuals with recent liver biopsy for suspected or confirmed NASH
NASH 2. Individuals of legal age, who have received full information on the organization of the research and have signed an informed consent form.
3. Person, affiliated to a social security scheme or beneficiary of such a scheme.
4. Person who has undergone a preliminary clinical examination appropriate to the research.
5. 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 likely can't join if

1. Known hypersensitivity to 68Ga-FAPI-46 or to any of the excipients or components of the radiopharmaceutical.
10. Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public Health Code.
11. Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care pursuant to articles L. 3212-1 and L. 3213-1.
12. Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public Health Code.
2. Infection with HCV/HBV.
3. Decompensated cirrhosis (ascites, hepatic insufficiency, hepatorenal syndrome, etc.).

See the full eligibility criteria

Who can join

1. Individuals with recent liver biopsy for suspected or confirmed NASH
NASH 2. Individuals of legal age, who have received full information on the organization of the research and have signed an informed consent form.
3. Person, affiliated to a social security scheme or beneficiary of such a scheme.
4. Person who has undergone a preliminary clinical examination appropriate to the research.
5. 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).

What rules you out

1. Known hypersensitivity to 68Ga-FAPI-46 or to any of the excipients or components of the radiopharmaceutical.
10. Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public Health Code.
11. Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care pursuant to articles L. 3212-1 and L. 3213-1.
12. Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public Health Code.
2. Infection with HCV/HBV.
3. Decompensated cirrhosis (ascites, hepatic insufficiency, hepatorenal syndrome, etc.).
4. Known hepatocellular carcinoma.
5. Steatogenic treatment (corticosteroid, Tamoxifen, Amiodarone, Methotrexate).
6. Excessive alcohol consumption in the last 5 years (>210 g/week in men, >140 g/week in women).
7. Clinically unstable state not suitable for 68Ga-FAPI-46 PET/CT scan.
8. Women of childbearing age without effective contraception.
9. Pregnant or breast-feeding mother.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.