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NCT Number: NCT06105411

Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions

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

Recruiting

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Key information

Conditions

Invasive Fungal Infections Bacterial Infections and Mycoses Infections Mycoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

  • Women who are pregnant or lactating.
  • Iron infusion within one week prior to scan

Treatment and study plan

68Ga-labelled TAFC PET/CT scan

Diagnostic Test

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

Primary outcomes

  1. Uptake of radiolabelled siderophore (68Ga-TAFC) in patients with proven/probable invasive Aspergillosis

    Time frame: At 60 minutes

    The maximum standardized uptake value (SUVmax) is widely used for measuring the uptake of FDG by malignant tissue.

Secondary outcomes

  1. Physiologic bio distribution

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

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

  2. Safety of 68Ga-TAFC-PET/CT

    Time frame: Evaluated within 24 hours of scan

    Adverse events defined by CTCAE v5

  3. Findings compared to CT and/or 18F-FDG PET/CT

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Abby Douglas

CONTACT

[email protected]

03 855 96136

Beatrice Sim

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Peter MacCallum Cancer Centre, Australia

Other

Registry information

Acronym: SPECIFIC

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 27, 2023
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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