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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509744-10-00 | Other Identifier | CTIS nr |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiopharmaceutical: gallium-68-deferoxamine ([68Ga]Ga-DFO-B) | Other | 100 MBq +/- 10% [68Ga]Ga-DFO-B which contains 100 µg DFO-B (see description in arm description) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Michon | Contact | 024 361 1111 | laura.michon@radboudumc.nl | |
| Roger Brüggemann | Contact | 024 361 1111 | roger.bruggemann@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Roger Brüggemann, PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RadboudUMC | Recruiting | Nijmegen | Netherlands |
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| ID | Term |
|---|---|
| D055732 | Pulmonary Aspergillosis |
| D001229 | Aspergillosis, Allergic Bronchopulmonary |
| ID | Term |
|---|---|
| D001228 | Aspergillosis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| D008172 |
| Lung Diseases, Fungal |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012141 | Respiratory Tract Infections |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |