iMagIng pulmonaRy Aspergillosis Using Gallium-68-dEferoxamine (MIRAGE)

Radboud University Medical Center

Status and phase: Enrolling; Phase 2

Conditions: Allergic Bronchopulmonary Aspergillosis; Chronic Pulmonary Aspergillosis; Pulmonary Aspergillosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06244979

2023-509744-10-00 (Other Identifier)

115136

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Intervention

Experimental group

Description:

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).

Treatment:

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