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NCT Number: NCT06244979

iMagIng pulmonaRy Aspergillosis Using Gallium-68-dEferoxamine

This is a single center open-label feasibility trial involving a single study visit for participants. The purpose of the study is to demonstrate the feasibility of [68Ga]Ga-DFO-B PET/CT (gallium-68-deferoxamine) for the visualization of pulmonary Aspergillus infection.

The incidence of fungal infections is on the rise and are associated with significant mortality. Diagnosis pulmonary aspergillosis can be can be challenging, often requiring invasive tests such as bronchoscopy and lung tissue biopsies. Molecular imaging, specifically using radiolabeled siderophores like [68Ga]Ga-DFO-B, offers a non-invasive and location-specific approach to visualize and evaluate infections. Siderophores, critical for pathogenic microbes like Aspergillus fumigatus, play a role in iron acquisition. Preclinical studies with radiolabeled deferoxamine (DFO-B) demonstrated distinct accumulation at infection sites. Additionally, [68Ga]Ga-DFO-B PET/CT may differentiate between Aspergillus infection and cancer, making it a promising non-invasive diagnostic tool for pulmonary aspergillosis.

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Key information

Conditions

Pulmonary Aspergillosis Allergic Bronchopulmonary Aspergillosis Aspergillosis Aspergillosis, Allergic Bronchopulmonary Bacterial Infections and Mycoses Chronic Pulmonary Aspergillosis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Fungal Mycoses Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient is at least 18 years old on the day of inclusion.
  • The patient has suspected chronic pulmonary aspergillosis or ABPA.
  • There is no significant interference with standard care and follow-up.

Exclusion criteria

  • The patient is pregnant or planning on becoming pregnant.
  • The patient has severe kidney dysfunction with eGFR < 30 ml/min/kg and/or receives dialysis.
  • The patient has (chronic) iron overload.
  • The patient has been receiving antifungal treatment for more than 48 hours prior to the study day.
  • The patient is not able to lie still in the scanner.

Treatment and study plan

Radiopharmaceutical: gallium-68-deferoxamine ([68Ga]Ga-DFO-B)

Other

100 MBq +/- 10% [68Ga]Ga-DFO-B which contains 100 µg DFO-B (see description in arm description)

Primary outcomes

  1. Standardized uptake values (SUV) of [68Ga]Ga-DFO-B

    Time frame: PET/CT will be performed 60 minutes after intravenous injection of [68Ga]Ga-DFO-B

    Measurement of the amount of radiotracer uptake ([68Ga]Ga-DFO-B) in suspected Aspergillus lesions in patients with pulmonary aspergillosis.

  2. Target-to-background ratios of [68Ga]Ga-DFO-B

    Time frame: PET/CT will be performed 60 minutes after intravenous injection of [68Ga]Ga-DFO-B

    Ratio of the signal intensity or uptake in suspected Aspergillus lesions (target) to the background signal intensity in the surrounding normal tissues in patients with pulmonary aspergillosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Michon

CONTACT

[email protected]

024 361 1111

Roger Brüggemann

CONTACT

[email protected]

024 361 1111

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Acronym: MIRAGE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2024
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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