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Study on 68Gallium-FAPI PET/CT Imaging for Patients with Chronic Inflammatory Disorders Using Gallium (68Ga) Chloride and 68-FAPI-46

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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 various chronic inflammatory and fibrotic diseases. These are conditions where the body's immune system causes long-term inflammation and scarring in tissues. The study will use a special imaging technique called PET/CT to look at these diseases. The imaging involves a radioactive tracer called 68-FAPI-46, which is injected into the body. This tracer helps to highlight areas of inflammation and fibrosis during the scan.

The purpose of the study is to observe and describe how the tracer behaves in the body and how it highlights different areas affected by the diseases. The study will involve a single injection of the tracer, followed by a PET/CT scan to capture images of the affected areas. This will help researchers understand the intensity and location of the disease activity in the body.

The study will take place over a period of time, with participants undergoing the imaging process at the start of the study. The information gathered from these images will be used to better understand the diseases and potentially improve future treatments. The study aims to provide valuable insights into how these diseases affect the body and how they can be better managed in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, eligibility is confirmed based on criteria such as age (18 or over) and diagnosis of a relevant chronic inflammatory or fibrotic disease.

    A comprehensive review of medical history and current health status is conducted to ensure alignment with study requirements.

  2. Step 2

    Preparation for imaging

    Preparation involves understanding the procedure for the 68Gallium-FAPI PET/CT imaging, which is used to assess inflammation and fibrosis in the body.

    Instructions are provided regarding any necessary dietary or medication adjustments prior to the imaging session.

  3. Step 3

    Administration of tracer

    The tracer, 68Ga-FAPI-46, is administered as an injectable solution. This tracer helps in visualizing specific areas of inflammation or fibrosis during the imaging process.

    The injection is performed under controlled conditions to ensure safety and accuracy.

  4. Step 4

    PET/CT imaging

    The PET/CT scan is conducted to capture detailed images of the body, highlighting areas where the tracer accumulates.

    The scan provides information on the intensity and location of tracer uptake, which is crucial for evaluating the condition.

  5. Step 5

    Data analysis

    The images obtained from the PET/CT scan are analyzed to measure the binding intensity using a standardized uptake value (SUV) max.

    This analysis helps in understanding the extent and nature of the inflammatory or fibrotic process.

  6. Step 6

    Follow-up assessments

    Additional assessments may be conducted to measure specific scores related to the pathology, such as reference scores, biomarkers, and functional parameters.

    These assessments help in providing a comprehensive evaluation of the disease and its progression.

  7. Step 7

    Completion of study participation

    The study is expected to conclude by October 21, 2026, with recruitment starting on October 1, 2024.

    Participants may be required to attend follow-up visits or provide additional information as part of the study's final assessments.

Who can join the trial?

4 criteria

  • Patient aged 18 or over
  • Affected by one of the conditions being studied
  • Meeting the agreed-upon classification criteria for the condition
  • Fitting the specific clinical situation related to the study

Who cannot join the trial?

4 criteria

  • Individuals with certain **inflammatory disorders** cannot participate. Inflammatory disorders are conditions where parts of the body become swollen, red, and painful.
  • Participants must be within specific age ranges, which are not specified here.
  • Both **male and female** participants are eligible, but certain criteria may exclude some individuals.
  • Individuals considered part of a **vulnerable population** are not included. Vulnerable populations are groups that may need special protection, like children or the elderly.
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Investigated drugs

68Gallium-FAPI is a radiotracer used in PET/CT imaging. It helps in identifying and visualizing areas of inflammation and fibrosis in the body. This medication is particularly useful in detecting chronic inflammatory and fibrotic diseases by highlighting the affected tissues during the imaging process.

What is already known about the treatment

68Gallium-FAPI – This medication is administered through a PET/CT scan, where it is used as a radiotracer to visualize inflammation and fibrosis in the body. Currently, it is being studied in clinical trials for its effectiveness in detecting chronic inflammatory and fibrotic diseases. The main therapeutic indication is to identify and assess the intensity of inflammation in various chronic conditions. At the molecular level, 68Gallium-FAPI binds to fibroblast activation protein, which is often overexpressed in inflamed or fibrotic tissues, allowing for precise imaging. It is classified as a diagnostic radiopharmaceutical agent.

Investigated diseases

  • Rheumatoid Arthritis

    Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically causes swelling, pain, and stiffness, often in the hands and feet. Over time, it can lead to joint damage and deformities. The disease progresses through periods of flares and remissions. It can also affect other parts of the body, including the skin, eyes, and lungs. The exact cause is unknown, but it involves the immune system attacking the body's own tissues.

  • Systemic Lupus Erythematosus

    Systemic lupus erythematosus is an autoimmune disease where the immune system attacks healthy tissues. It can affect the skin, joints, kidneys, brain, and other organs. Symptoms vary widely but often include fatigue, joint pain, and skin rashes. The disease can progress with periods of increased activity, known as flares, and times of remission. The exact cause is not fully understood, but it involves genetic and environmental factors. It is more common in women than men.

  • Sarcoidosis

    Sarcoidosis is an inflammatory disease characterized by the formation of small clumps of inflammatory cells, called granulomas, in various organs. It most commonly affects the lungs and lymph nodes but can involve any organ. Symptoms can include cough, shortness of breath, and fatigue. The progression of sarcoidosis varies; it can resolve on its own or become chronic. The cause of sarcoidosis is unknown, but it is thought to involve an abnormal immune response. It can affect people of any age, but it is more common in adults.

  • Idiopathic Pulmonary Fibrosis

    Idiopathic pulmonary fibrosis is a chronic lung disease that results in scarring of the lung tissue. This scarring makes it difficult for the lungs to work properly, leading to symptoms like shortness of breath and a persistent dry cough. The disease progresses over time, with lung function gradually declining. The cause of idiopathic pulmonary fibrosis is unknown, but it is believed to involve genetic and environmental factors. It primarily affects older adults. The progression rate can vary significantly among individuals.

  • Scleroderma

    Scleroderma is a group of autoimmune diseases that cause hardening and tightening of the skin and connective tissues. It can affect only the skin or involve internal organs, such as the heart, lungs, and kidneys. Symptoms include skin thickening, joint pain, and digestive issues. The disease progresses differently in each person, with some experiencing mild symptoms and others having severe complications. The exact cause is unknown, but it involves the immune system attacking the body's own tissues. It is more common in women than men.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508190-84-01Protocol code29BRC23.0029Estimated enrolment390 patientsSponsorCHU de Brest

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