Siderophore-labelled Position Emission Tomography for Correlating Invasive Fungal InfeCtions

Study Overview
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Brief Summary
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This trial will demonstrate localised uptake of a radiolabelled fungal component (siderophore) in areas of known specific invasive fungal (Aspergillus) infection.

Detailed Description
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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.

Official Title
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Siderophore-labelled Position Emission Tomography for Correlating Invasive Fungal InfeCtions

Conditions
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Invasive Fungal Infections

Intervention / Treatment
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* Diagnostic Test: 68Ga-labelled TAFC PET/CT scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has provided written informed consent Aged 18 years or older at written informed consent Within 2 weeks of proven or probable invasive fungal infection (IFI) diagnosis as per EORTC criteria Imaging consistent with invasive pulmonary aspergillosis on CT or FDG-PET/CT with lesions at least 8mm in diameter 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: Women who are pregnant or lactating. Iron infusion within one week prior to scan

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 68Ga-labelled TAFC PET/CT scan|68Ga-labelled TAFC PET/CT scan (whole body)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Invasive Fungal Infections, Siderophore, PET, 68Ga-labelled TAFC PET/CT scan, Siderophore-labelled Position Emission tomography, Aspergillus spp.