iMagIng pulmonaRy Aspergillosis Using Gallium-68-dEferoxamine

Phase 2

Recruiting

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

• Registration Number: NCT06244979
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-03
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-06
• Status Verified: 2025-05
• Study Start: 2025-05-01
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Standardized uptake values (SUV) of [68Ga]Ga-DFO-B	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	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.

Trial Locations

Locations (1)

RadboudUMC; 🇳🇱 Nijmegen, Netherlands