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Study on Liver Fibrosis Assessment Using 68Ga-FAPI-46 Imaging in Patients with Suspected or Confirmed Nonalcoholic Steatohepatitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a liver condition known as Nonalcoholic Steatohepatitis (NASH), which is a type of liver disease that occurs when fat builds up in the liver, causing inflammation and damage. The study will use a special imaging technique called Fibroblast Activation Protein Imaging to assess the stage of liver fibrosis, which is the scarring of liver tissue. The imaging involves a substance known as 68Ga-FAPI-46, which is a radiopharmaceutical precursor. This means it is a type of drug that uses a small amount of radioactive material to help doctors see how much scarring is present in the liver.

The purpose of the study is to determine if the uptake of 68Ga-FAPI-46 in the liver, as seen on a PET/CT scan (a type of imaging test that helps visualize organs and tissues), varies according to different stages of liver fibrosis. These stages range from mild to severe, with stage 4 being cirrhosis, which is the most advanced form of liver scarring. Participants in the study will have already undergone a liver biopsy, which is a procedure where a small piece of liver tissue is removed and examined to confirm the presence of NASH.

Throughout the study, the intensity of 68Ga-FAPI-46 uptake will be measured at the sites where liver biopsies were taken. This will help researchers understand how the imaging results correlate with the actual fibrosis stage determined by the biopsy. The study will also explore if this imaging method can detect other areas of fibrosis or inflammation in the body, and potentially even cancer, as this tracer has shown promise in identifying various types of cancer. The study is expected to continue until August 2027.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted. This includes a review of the recent liver biopsy results for suspected or confirmed nonalcoholic steatohepatitis (NASH).
A preliminary clinical examination is performed to ensure suitability for the research.
Step 2
Consent and eligibility confirmation
Participants must be of legal age and provide informed consent after receiving full information about the study.
Eligibility is confirmed based on the histological stage of fibrosis obtained from the biopsy, ensuring an equal number of participants with stages greater than 2 and less than or equal to 2.
Step 3
Imaging procedure
Participants undergo a specialized imaging procedure using 68Ga-FAPI-46, a radiopharmaceutical precursor administered through an intravenous infusion.
The imaging is performed using PET/CT technology to measure the uptake intensity of 68Ga-FAPI-46 at the liver biopsy sites.
Step 4
Data collection and analysis
The primary endpoint involves measuring the uptake intensity of 68Ga-FAPI-46 using standardized uptake values (SUV) at the biopsy sites.
Secondary endpoints include determining SUV threshold values for different fibrosis stages, analyzing the distribution of SUV across the liver, and identifying any abnormal uptake areas outside normal zones.
Step 5
Follow-up and conclusion
The study aims to conclude by August 2027, with ongoing follow-up to monitor the outcomes and gather comprehensive data.
The results will contribute to understanding the relationship between 68Ga-FAPI-46 uptake and liver fibrosis stages.

Who can join the trial?

5 criteria

Individuals who have recently had a liver biopsy to check for or confirm **NASH**. **NASH** stands for **Non-Alcoholic Steatohepatitis**, a liver condition.
Individuals who are of legal adult age and have been fully informed about the research. They must have signed a document agreeing to participate, known as an informed consent form.
Individuals who are part of a social security scheme or are beneficiaries of such a scheme. This means they have some form of health insurance or social protection.
Individuals who have had a preliminary medical examination that is suitable for the research. This means they have been checked by a doctor to ensure they are fit to participate.
Individuals whose liver biopsy results show a specific stage of **fibrosis**. **Fibrosis** is a term for scarring of the liver. The study requires a balanced number of participants with different stages of fibrosis, and at least 16 participants in each of the four groups of fibrosis stages.

Who cannot join the trial?

2 criteria

Patients with **non-alcoholic hepatic steatosis** or **alcoholic hepatic steatosis** cannot participate. This means if you have a condition where fat builds up in the liver, either due to alcohol or not, you are not eligible.
Patients who are part of a **vulnerable population** are not eligible. This generally refers to groups who may need special protection or care, such as children, pregnant women, or those with certain disabilities.

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CHRU De Nancy
Vandoeuvre Les Nancy, France

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Investigated drugs

68Ga-FAPI-46 is a special imaging agent used in this study. It helps doctors see how much of it is taken up by the liver in patients who have had a biopsy for suspected or confirmed nonalcoholic steatohepatitis (NASH). This imaging agent is used in a type of scan called PET/CT, which allows doctors to assess the stage of liver fibrosis. The study aims to determine if the uptake of this agent varies depending on the severity of liver fibrosis, which is categorized into different stages based on biopsy results.

(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-Cyano-4,4-Difluoropyrrolidin-1-Yl)-2-Oxoethylcarbamoyl)-Quinolin-6-Yl)(Methyl)Amino)-Propyl)Piperazin-1-Yl)-2-Oxoethyl)-68Ga-[1,4,7,10]-Tetraazacyclododecane-1,4,7-Triyl)Triacetate

What is already known about the treatment

68Ga-FAPI-46 – This medication is administered through an injection and is used in imaging procedures, specifically PET/CT scans. It is currently being studied in clinical trials to assess its effectiveness in evaluating liver fibrosis stages in patients with suspected or confirmed nonalcoholic steatohepatitis. The main therapeutic indication is to help visualize and differentiate the intensity of liver fibrosis, which can range from mild to severe, including cirrhosis. At the molecular level, 68Ga-FAPI-46 targets fibroblast activation protein, which is often overexpressed in fibrotic tissues, allowing for enhanced imaging contrast. It is classified pharmacologically as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Non-Alcoholic Fatty Liver Disease
This condition involves the accumulation of excess fat in the liver of people who drink little or no alcohol. It often progresses slowly and may not cause symptoms initially. Over time, it can lead to liver inflammation and damage, potentially resulting in scarring of the liver tissue. The disease can advance to more severe forms, such as non-alcoholic steatohepatitis, which involves liver inflammation and can progress to cirrhosis. Cirrhosis is characterized by severe scarring and impaired liver function. The progression of the disease varies among individuals, and some may experience more rapid advancement than others.
Alcoholic Fatty Liver Disease
This disease is caused by excessive alcohol consumption, leading to fat accumulation in the liver. Initially, it may not present noticeable symptoms, but continued alcohol intake can exacerbate the condition. As the disease progresses, it can cause liver inflammation and damage, known as alcoholic hepatitis. If unchecked, it may lead to fibrosis, where scar tissue forms in the liver, and eventually cirrhosis, which severely affects liver function. The progression of the disease is influenced by the amount and duration of alcohol consumption. Reducing alcohol intake can slow or halt the progression of the disease.