Pulmonary AspergillosisPhase 2MIRAGENCT06244979
iMagIng pulmonaRy Aspergillosis Using Gallium-68-dEferoxamine
A Phase 2 study testing Radiopharmaceutical: gallium-68-deferoxamine ([68Ga]Ga-DFO-B) in people with Pulmonary Aspergillosis and Chronic Pulmonary Aspergillosis, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Aspergillosis, Chronic Pulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis
- What is being tested?
- Radiopharmaceutical: gallium-68-deferoxamine ([68Ga]Ga-DFO-B)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2025to 31 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pulmonary Aspergillosis, Chronic Pulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis
- Being tested
- Radiopharmaceutical: gallium-68-deferoxamine ([68Ga]Ga-DFO-B)
- Medical subject headings
- Pulmonary Aspergillosis, Aspergillosis, Allergic Bronchopulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients will undergo a PET/CT scan at t=60 min after a single intravenous injection of a fixed dose of 100 MBq +/- 10% [68Ga]Ga-DFO-B (gallium-68-deferoxamine) which contains 100 µg deferoxamine (DFO-B). Receives: Other: Radiopharmaceutical: gallium-68-deferoxamine ([68Ga]Ga-DFO-B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake values (SUV) 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.
Measured: PET/CT will be performed 60 minutes after intravenous injection of [68Ga]Ga-DFO-B
Target-to-background ratios 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.
Measured: PET/CT will be performed 60 minutes after intravenous injection of [68Ga]Ga-DFO-B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 May 2025
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary AspergillosisStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roger Brüggemann, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244979
- Sponsor's protocol ID
- 115136
- Other IDs
- 2023-509744-10-00, 2023
- Acronym
- MIRAGE
- Status last verified
- Aug 2026
- First submitted
- 3 Jan 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iMagIng pulmonaRy Aspergillosis Using Gallium-68-dEferoxamine
- ClinicalTrials.gov ID
- NCT06244979
- Acronym / sponsor ID
- MIRAGE / 115136
- Conditions
- Pulmonary Aspergillosis, Chronic Pulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Radiopharmaceutical: gallium-68-deferoxamine ([68Ga]Ga-DFO-B)Patients will undergo a PET/CT scan at t=60 min after a single intravenous injection of a fixed dose of 100 MBq +/- 10% [68Ga]Ga-DFO-B (gallium-68-deferoxamine) which contains 100 µg deferoxamine (DFO-B). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiopharmaceutical: gallium-68-deferoxamine ([68Ga]Ga-DFO-B)100 MBq +/- 10% [68Ga]Ga-DFO-B which contains 100 µg DFO-B (see description in arm description) | Other | Intervention |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Aspergillosis
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RecruitingPhase 3
A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis, CPA
Not yet recruitingPhase 1
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Chronic Pulmonary Aspergillosis
Active, not recruitingPhase 2
Interferon-gamma as Adjunctive Therapy in Chronic Pulmonary Aspergillosis: a Randomised Feasibility Study
Chronic Pulmonary Aspergillosis, Aspergillosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Brüggemann, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiopharmaceutical: gallium-68-deferoxamine ([68Ga]Ga-DFO-B) in people with Pulmonary Aspergillosis and Chronic Pulmonary Aspergillosis, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.