Invasive Fungal Infections
Conditions
Keywords
Invasive Fungal Infections, Siderophore, PET, Siderophore-labelled Position Emission tomography, 68Ga-labelled TAFC PET/CT scan, Aspergillus spp.
Brief summary
This trial will demonstrate localised uptake of a radiolabelled fungal component (siderophore) in areas of known specific invasive fungal (Aspergillus) infection.
Detailed description
This open label, single centre, proof of concept pilot imaging trial will evaluate technique for the diagnosis of invasive Aspergillus infection. It aims to demonstrate uptake of the gallium-siderophore tracer at sites of known proven/probable invasive aspergillus app infection. It will also assess the safety and tolerability of this technique. 10 patients within 2 weeks of proven or probable invasive fungal infection (IFI) diagnosis will be recruited to this study over a period of 12-24 months.
Interventions
DIAGNOSTIC_TEST68Ga-labelled TAFC PET/CT scan
68Ga-labelled TAFC PET/CT scan (whole body)
Sponsors
Peter MacCallum Cancer Centre, Australia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient has provided written informed consent 2. Aged 18 years or older at written informed consent 3. Within 2 weeks of proven or probable or possible invasive fungal infection (IFI) diagnosis as per EORTC criteria 4. Imaging consistent with invasive pulmonary aspergillosis on CT or FDG-PET/CT with lesions at least 8mm in diameter 5. Patient is willing and able to comply with the protocol for the duration of the study including scheduled visits such as follow up
Exclusion criteria
1. Women who are pregnant or lactating. 2. Iron infusion within one week prior to scan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of radiolabelled siderophore (68Ga-TAFC) in patients with proven/probable invasive Aspergillosis | At 60 minutes | The maximum standardized uptake value (SUVmax) is widely used for measuring the uptake of FDG by malignant tissue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physiologic bio distribution | Evaluated up to 3 hours following injection of radiotracer | SUVmax in mediastinal blood pool, and any organs with uptake including liver, spleen and marrow |
| Safety of 68Ga-TAFC-PET/CT | Evaluated within 24 hours of scan | Adverse events defined by CTCAE v5 |
| Findings compared to CT and/or 18F-FDG PET/CT | At 60 minutes | Descriptive comparison of the siderophore PET to standard of care imaging - looking at areas of uptake and if this corresponds to areas of presumed infection on SOC PET or CT |
Countries
Australia
Contacts
Primary ContactAbby Douglas
Backup ContactBeatrice Sim
Outcome results
None listed