iMagIng pulmonaRy Aspergillosis Using Gallium-68-dEferoxamine

Allergic Bronchopulmonary Aspergillosis Clinical Trial

— MIRAGE  

Official title:

iMagIng pulmonaRy Aspergillosis Using Gallium-68-dEferoxamine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06244979
• Other study ID #: 115136
• Secondary ID: 2023-509744-10-0
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: December 2023
• Source: Radboud University Medical Center
• Contact: Laura Michon
• Phone: 024 361 1111
• Email: laura.michon[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: March 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Bronchopulmonary Aspergillosis
• Aspergillosis
• Chronic Pulmonary Aspergillosis
• Pulmonary Aspergillosis

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	PET/CT will be performed 60 minutes after intravenous injection of [68Ga]Ga-DFO-B
Primary	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.	PET/CT will be performed 60 minutes after intravenous injection of [68Ga]Ga-DFO-B