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Study of inhaled liposomal amphotericin B and technetium-99m to assess lung distribution in patients with chronic pulmonary aspergillosis

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What is this trial about?

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

This study focuses on patients with Chronic Pulmonary Aspergillosis, a fungal infection that affects the lungs. The research examines a treatment called AmBisome, which contains liposomal amphotericin B, a medication used to treat fungal infections. The treatment will be combined with a radioactive substance called Technetium-99m and given through inhalation using a nebulizer, which turns the medication into a fine mist that can be breathed in.

The main purpose of this study is to understand how the inhaled medication spreads throughout the lungs and to find the best way to give this treatment. During the study, special imaging called single-photon emission computed tomography will be used to see where the medication goes in the lungs. The researchers will also measure how much of the medication gets into the blood.

The treatment will be given over two days through a nebulizer. Throughout the study, the researchers will monitor how well patients tolerate the treatment and any side effects they may experience. They will also ask patients about their satisfaction with the treatment and how convenient it is to use.

The research process

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

  1. Step 1

    Initial medication preparation

    You will receive liposomal amphotericin B (AmBisome) marked with a special substance called Technetium-99m that allows tracking the medication in your body

    The medication will be prepared specifically for inhalation therapy

  2. Step 2

    Inhalation procedure

    You will receive the medication through a special device called a nebulizer

    The nebulizer transforms the medication into a fine mist that you can inhale

    The medical team will guide you through the proper inhalation technique

  3. Step 3

    Imaging examination

    After inhaling the medication, you will undergo a special type of scan called SPECT/CT

    This scan shows where the medication has settled in your lungs

    The procedure is painless and requires lying still while the scanner takes pictures

  4. Step 4

    Blood sampling

    Blood samples will be taken to measure how much medication has entered your bloodstream

    This helps understand how the medication spreads through your body

  5. Step 5

    Side effect monitoring

    Your breathing function will be checked regularly

    You will be monitored for any side effects or reactions to the medication

    You will complete a questionnaire about your experience with the treatment

Who can join the trial?

6 criteria

  • Must be at least 18 years old at the time of joining the study
  • Must have been diagnosed with chronic pulmonary aspergillosis (a long-term fungal infection affecting the lungs)
  • Patient's participation must not interfere with their regular medical care and follow-up appointments
  • Both men and women can participate
  • Must be able to follow study procedures and attend scheduled visits
  • Must not belong to any vulnerable population groups (such as people who cannot make decisions for themselves)

Who cannot join the trial?

13 criteria

  • Age below 18 years or above 65 years
  • Known allergy or sensitivity to amphotericin B (an antifungal medication) or similar medications
  • Pregnancy or breastfeeding
  • Severe respiratory problems that could affect breathing during nebulization (inhaling medication as a mist)
  • Active lung bleeding
  • Previous exposure to radiation in the past 12 months
  • Unable to follow the nebulization procedure correctly
  • Current participation in other clinical trials
  • Serious heart conditions
  • Severe kidney problems
  • History of adverse reactions to radioactive substances
  • Mental conditions that could affect ability to provide informed consent
  • Any condition that could interfere with the study procedures or patient safety
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Investigated drugs

  • Liposomal Amphotericin B (AmBisome)

    is a medication used to treat serious fungal infections. In this trial, it is specially prepared as a nebulized solution that patients can inhale through a nebulizer. The medication is mixed with a radioactive substance called Technetium-99m, which allows researchers to track exactly where the medicine goes in the lungs. This helps them understand how well the medication spreads throughout the lungs when it's inhaled, which is particularly important for treating fungal infections in the lungs like aspergillosis.

  • Technetium-99m

    is a medical tracer that produces very low levels of radiation. It is commonly used in medical imaging to help doctors see how substances move through the body. In this study, it is attached to the AmBisome medication to make it visible during scanning, allowing researchers to track how the medication distributes in the lungs after inhalation.

What is already known about the treatment

Liposomal Amphotericin B (AmBisome) – A specialized antifungal medication delivered through nebulization (inhalation) that contains amphotericin B enclosed in tiny lipid spheres called liposomes. This formulation is being studied for treating chronic pulmonary aspergillosis, a serious fungal infection affecting the lungs. The liposomal delivery system helps reduce the medication's toxicity while allowing it to reach infected lung tissue directly when inhaled. The drug works by binding to ergosterol in fungal cell membranes, creating pores that lead to cell death, and belongs to the polyene antifungal class of medications.

Investigated diseases

Chronic Pulmonary Aspergillosis - A fungal infection that develops in the lungs caused by Aspergillus species, typically occurring over several months or years. The condition involves the gradual development of cavities in the lungs, which may be accompanied by the formation of fungal balls. The infection usually affects people who already have other lung conditions or weakened immune systems. The disease causes the lung tissue to develop scarring over time, and may lead to the thickening of the walls of air spaces within the lungs. Symptoms typically develop gradually and include persistent cough, shortness of breath, and mild fever.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-521770-34-00Estimated enrolment18 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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