Allergic Bronchopulmonary Aspergillosis, Chronic Pulmonary Aspergillosis, Pulmonary Aspergillosis
Conditions
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.
Interventions
OTHERRadiopharmaceutical: 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)
Sponsors
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORRoger Brüggemann, PhD
Radboud University Medical Center
Outcome results
None listed