Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions (SPECIFIC)

Peter MacCallum Cancer Centre, Australia

Status: Enrolling

Conditions: Invasive Fungal Infections

Treatments: Diagnostic Test: 68Ga-labelled TAFC PET/CT scan

Study type: Observational

Funder types: Other

Identifiers

NCT06105411

SPECIFIC

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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