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Study on Imaging Lung Aspergillosis Using Gallium-68 Deferoxamine for Patients with Pulmonary Aspergillosis

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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 lung infection called pulmonary aspergillosis. This condition is caused by a type of fungus that can affect the lungs, leading to various respiratory issues. The study is exploring a new way to visualize this infection using a special imaging technique. The treatment being tested involves a combination of two substances: deferoxamine mesilate and gallium (68Ga) chloride. These substances are combined to form a compound called 68Ga-DFO, which is used in a type of scan known as a PET/CT scan. This scan helps doctors see the infection in the lungs more clearly.

The purpose of the study is to see if this new imaging method can effectively show the presence of the fungal infection in the lungs. Participants in the study will receive the 68Ga-DFO compound through an intravenous injection, which means it is given directly into a vein. After the injection, a PET/CT scan will be performed to capture detailed images of the lungs. This process is expected to take place over a short period, typically within a day.

The study aims to gather information on how well the 68Ga-DFO compound highlights the infection in the lungs. Researchers will look at how the compound is taken up in different parts of the lungs and compare it to various factors like iron levels in the body and the presence of other infections. This research could lead to better ways of diagnosing and understanding pulmonary aspergillosis, potentially improving treatment options for those affected by this condition.

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, an initial assessment is conducted to confirm eligibility. This includes verifying that the patient is at least 18 years old and has suspected chronic pulmonary aspergillosis or allergic bronchopulmonary aspergillosis (ABPA).

  2. Step 2

    Medication administration

    The patient receives an intravenous administration of deferoxamine mesilate and gallium (68ga) chloride. These substances are used to prepare the body for imaging procedures.

  3. Step 3

    Imaging procedure

    A PET/CT scan is performed to visualize the pulmonary aspergillus infection. The scan uses the radioactively labeled deferoxamine to detect the presence of aspergillus lesions in the lungs.

  4. Step 4

    Data collection

    Data is collected on the uptake of the labeled deferoxamine in the suspected aspergillus lesions. This includes measuring the quantitative uptake and target-to-background ratios.

  5. Step 5

    Analysis of results

    The patterns of uptake are analyzed to understand the different forms of pulmonary aspergillosis and any co-infections. Comparisons are made with the patient's iron status and blood cell counts.

  6. Step 6

    Follow-up

    Regular follow-up is conducted to monitor the patient's condition and any changes in the uptake patterns over time. This ensures there is no significant interference with standard care and follow-up.

Who can join the trial?

3 criteria

  • The patient must be at least 18 years old on the day they join the study.
  • The patient must have a suspected case of **chronic pulmonary aspergillosis** or **ABPA**. **Chronic pulmonary aspergillosis** is a long-term lung infection caused by a type of fungus called Aspergillus. **ABPA** stands for **Allergic Bronchopulmonary Aspergillosis**, which is an allergic reaction in the lungs to the Aspergillus fungus.
  • Participating in the study should not significantly interfere with the patient's regular medical care and follow-up appointments.

Who cannot join the trial?

7 criteria

  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, meaning they may need special protection or care.
  • Patients who do not have a confirmed diagnosis of pulmonary aspergillosis, which is a type of lung infection caused by a fungus called Aspergillus.
  • Patients who are unable to undergo a PET/CT scan, which is a type of imaging test that helps doctors see inside the body.
  • Patients who have any medical condition that might interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the study may not be safe for them or their baby.
  • Patients who are currently participating in another clinical trial, as this could affect the results of the study.
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Investigated drugs

[68Ga]Ga-DFO-B is a special imaging agent used in PET/CT scans. It helps doctors see infections in the lungs caused by a fungus called Aspergillus. This agent is designed to bind to the fungus, making it visible on the scan, which helps in diagnosing and understanding the infection better.

What is already known about the treatment

Gallium-68-deferoxamine (68Ga-DFO-B) – This medication is administered through a PET/CT scan, where it is used as a radiotracer to visualize infections in the lungs. It is currently being studied in clinical trials for its effectiveness in detecting pulmonary aspergillosis, a type of lung infection. The main therapeutic indication is to aid in the diagnosis of this infection by highlighting areas of infection in imaging studies. At the molecular level, Gallium-68 binds to deferoxamine, which targets areas of infection, allowing for clear imaging results. It is classified as a diagnostic radiopharmaceutical agent.

Investigated diseases

Pulmonary aspergillosis – This is a fungal infection that affects the lungs, caused by the Aspergillus species. It can occur in different forms, including allergic bronchopulmonary aspergillosis, chronic pulmonary aspergillosis, and invasive aspergillosis. The disease typically begins when the spores of the fungus are inhaled and settle in the lung tissue. In individuals with weakened immune systems or existing lung conditions, the fungus can grow and cause symptoms such as coughing, wheezing, and difficulty breathing. Over time, the infection can lead to the formation of fungal balls, known as aspergillomas, or cause more widespread lung damage. The progression and severity of the disease can vary depending on the individual's immune response and overall health.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509744-10-00Protocol code115136Estimated enrolment10 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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