Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial will demonstrate localised uptake of a radiolabelled fungal component (siderophore) in areas of known specific invasive fungal (Aspergillus) infection.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-labelled TAFC PET/CT scan | Diagnostic Test | 68Ga-labelled TAFC PET/CT scan (whole body) |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of radiolabelled siderophore (68Ga-TAFC) in patients with proven/probable invasive Aspergillosis | The maximum standardized uptake value (SUVmax) is widely used for measuring the uptake of FDG by malignant tissue. | At 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Physiologic bio distribution | SUVmax in mediastinal blood pool, and any organs with uptake including liver, spleen and marrow | Evaluated up to 3 hours following injection of radiotracer |
| Safety of 68Ga-TAFC-PET/CT |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients aged 18 years or older at written informed consent who have proven or probable invasive fungal infection (IFI) diagnosis with imaging consistent with invasive pulmonary aspergillosis on CT or FDG-PET/CT with lesions at least 8mm in diameter. They are also willing and able to comply with the protocol for the duration of the study including scheduled visits such as follow up.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abby Douglas | Contact | 03 855 96136 | Abby.Douglas@petermac.org | |
| Beatrice Sim | Contact | Beatrice.Sim@petermac.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | Victoria | 3000 | Australia |
Not provided
| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Adverse events defined by CTCAE v5
| Evaluated within 24 hours of scan |
| Findings compared to CT and/or 18F-FDG PET/CT | 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 | At 60 minutes |