Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions

Invasive Fungal Infections Clinical Trial

— SPECIFIC  

Official title:

Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06105411
• Other study ID #: SPECIFIC
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: April 2026

Study information

• Verified date: March 2024
• Source: Peter MacCallum Cancer Centre, Australia
• Contact: Abby Douglas
• Phone: 03 855 96136
• Email: Abby.Douglas[@]petermac.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Invasive Fungal Infections
• Mycoses

Intervention

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

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Peter MacCallum Cancer Centre, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Safety of 68Ga-TAFC-PET/CT	Adverse events defined by CTCAE v5	Evaluated within 24 hours of scan
Secondary	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