NCT06244979

iMagIng pulmonaRy Aspergillosis Using Gallium-68-dEferoxamine

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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

Interventions

Type	Name	Description
OTHER	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)

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-02-06
• Last updated: 2025-05-22

Locations

1 site across 1 country: Netherlands