About this trial
This trial will demonstrate localised uptake of a radiolabelled fungal component (siderophore) in areas of known specific invasive fungal (Aspergillus) infection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient has provided written informed consent
Aged 18 years or older at written informed consent
Within 2 weeks of proven or probable or possible 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
Disqualifiers
Women who are pregnant or lactating.
Iron infusion within one week prior to scan
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
68Ga-labelled TAFC PET/CT scan
Diagnostic test68Ga-labelled TAFC PET/CT scan (whole body)
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Physiologic bio distribution
SUVmax in mediastinal blood pool, and any organs with uptake including liver, spleen and marrow
Safety of 68Ga-TAFC-PET/CT
Adverse events defined by CTCAE v5
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
Sponsors and contacts
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