SPECIFIC: Siderophore-labelled Position Emission Tomography for Correlating Invasive Fungal InfeCtions

Sponsor

Peter MacCallum Cancer Centre, Australia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06105411

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Invasive Fungal Infections	Diagnostic Test: 68Ga-labelled TAFC PET/CT scan

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 Design

Study Type:

Observational

Anticipated Enrollment :

10 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Siderophore-labelled Position Emission Tomography for Correlating Invasive Fungal InfeCtions

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Apr 1, 2026

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient has provided written informed consent
Aged 18 years or older at written informed consent
Within 2 weeks of proven or probable 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
Patient is willing and able to comply with the protocol for the duration of the study including scheduled visits such as follow up