Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions

Recruiting

• Conditions: Invasive Fungal Infections

• Registration Number: NCT06105411
• Lead Sponsor: Peter MacCallum Cancer Centre, Australia

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-27
• Study Start: 2023-12-01
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-28
• Last Update Posted: 2025-09-05
• Primary Completion: 2026-10
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Uptake of radiolabelled siderophore (68Ga-TAFC) in patients with proven/probable invasive Aspergillosis	At 60 minutes	The maximum standardized uptake value (SUVmax) is widely used for measuring the uptake of FDG by malignant tissue.

Secondary Outcome Measures

Name	Time	Method
Safety of 68Ga-TAFC-PET/CT	Evaluated within 24 hours of scan	Adverse events defined by CTCAE v5
Findings compared to CT and/or 18F-FDG PET/CT	At 60 minutes	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
Physiologic bio distribution	Evaluated up to 3 hours following injection of radiotracer	SUVmax in mediastinal blood pool, and any organs with uptake including liver, spleen and marrow

Trial Locations

Locations (1)

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia