Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeter MacCallum Cancer Centre, Australia

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 68Ga-labelled TAFC PET/CT scan

    Diagnostic test

    68Ga-labelled TAFC PET/CT scan (whole body)

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
At 60 minutes

Secondary outcomes

1

Physiologic bio distribution

SUVmax in mediastinal blood pool, and any organs with uptake including liver, spleen and marrow

Time frame
Evaluated up to 3 hours following injection of radiotracer
2

Safety of 68Ga-TAFC-PET/CT

Adverse events defined by CTCAE v5

Time frame
Evaluated within 24 hours of scan
3

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

Time frame
At 60 minutes

Other outcomes

Sponsors and contacts

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