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Study on the Use of Fludeoxyglucose (18F) in PET/CT Scans for Young Patients with Histiocytosis

Registered drugNo placebo
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What is this trial about?

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

This clinical trial focuses on a condition known as histiocytosis, which involves the excessive growth of certain immune cells called histiocytes. The study aims to explore the use of a special imaging technique called PET/CT to better understand the disease in young patients. The imaging process uses a substance called Fludeoxyglucose (18F), which is a type of sugar that helps highlight areas of the body during scans. This trial will help determine the benefits and safety of using this imaging method in children and teenagers with histiocytosis.

Participants in the study will undergo PET/CT imaging to assess the molecular profile of their condition. If a specific mutation is detected, it will be monitored over time. The study will evaluate how well the imaging technique works in providing useful information about the disease and its progression. The trial will also look at how the disease responds to treatment and monitor any side effects that may occur.

The goal of the study is to improve understanding of histiocytosis and to see if using Fludeoxyglucose (18F) in PET/CT imaging can provide valuable insights into the disease. This research could potentially lead to better ways to monitor and manage histiocytosis in young patients, helping to improve their overall care and outcomes.

The research process

The trial runs in 6 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, the patient's eligibility is confirmed. This includes being under 18 years of age and having a confirmed or suspected condition known as histiocytosis.

    The patient or their guardian must sign an informed consent form, which is a legal requirement to participate in the trial.

  2. Step 2

    Baseline evaluation

    A baseline evaluation is conducted to assess the patient's current health status. This may involve various tests and assessments to gather initial data.

  3. Step 3

    Administration of fludeoxyglucose (18F)

    The patient receives an injection of fludeoxyglucose (18F), a solution used for imaging purposes. This is administered intravenously, meaning it is injected directly into a vein.

    The dosage ranges from 200 to 2200 MBq/ml, depending on the specific requirements of the imaging procedure.

  4. Step 4

    PET/CT imaging

    Following the injection, a PET/CT scan is performed. This imaging technique helps in visualizing the molecular status of the patient's condition.

    The scan is used to determine the clinical benefit and safety of using fludeoxyglucose (18F) in patients with histiocytosis.

  5. Step 5

    Monitoring and follow-up

    The patient is monitored for any changes in their condition. This includes tracking event-free survival (EFS), which refers to the time during and after treatment that the patient remains free of certain negative events.

    Secondary outcomes such as progression-free survival (PFS), overall survival (OS), and overall response rate (ORR) are also evaluated.

    The rate of reactivation after two years and any adverse events are recorded and analyzed.

  6. Step 6

    Completion of trial

    The trial is expected to conclude by March 30, 2026. At this point, all data collected will be analyzed to determine the overall effectiveness and safety of the treatment.

Who can join the trial?

3 criteria

  • The patient must be under 18 years old at the time of joining the study.
  • The patient must have a confirmed or suspected condition called **histiocytosis**. This means there is an unusual increase in certain cells in the body, based on previous test results.
  • The patient or their guardian must sign a document called **informed consent**. This means they agree to participate in the study and understand what it involves, following the current legal rules.

Who cannot join the trial?

1 criterion

  • There are no specific reasons listed that would prevent a patient from participating in this study.
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Investigated drugs

Fludeoxyglucose (18F-FDG) is a type of radioactive sugar used in PET/CT imaging. In this clinical trial, it helps doctors see how the body is functioning at a molecular level. It is particularly useful for identifying areas of high metabolic activity, which can indicate the presence of certain diseases, such as histiocytosis, in juvenile patients. The trial aims to determine the benefits and safety of using this imaging technique in young patients.

What is already known about the treatment

Fludeoxyglucose (18F-FDG) – This medication is administered intravenously and is used in PET/CT imaging. It is currently being studied for its effectiveness and safety in juvenile patients with histiocytosis, a condition involving abnormal growth of histiocytic cells. The main therapeutic indication is to assist in imaging for better diagnosis and treatment planning. At the molecular level, Fludeoxyglucose (18F-FDG) acts by mimicking glucose, allowing it to be taken up by cells, particularly those with high metabolic activity, such as cancer cells, which can then be visualized in imaging. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Histiocytic Cell Proliferation – This condition involves an abnormal increase in the number of histiocytes, which are a type of immune cell. These cells can accumulate in various tissues and organs, potentially leading to inflammation and tissue damage. The progression of the disease can vary, with some individuals experiencing mild symptoms while others may have more severe manifestations. The condition can affect different parts of the body, including the skin, bones, and internal organs. Symptoms may include fever, fatigue, and weight loss, depending on the organs involved. The exact cause of the proliferation is not always clear, and it may be associated with genetic or environmental factors.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-515895-11-00Protocol codeHISTIOGENEstimated enrolment150 patientsSponsorInstytut Matki I Dziecka

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