Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-labelled TAFC PET/CT scan.
- Who it may be relevant to
- Registry conditions: Invasive Fungal Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test 68Ga-labelled TAFC PET/CT scan
68Ga-labelled TAFC PET/CT scan (whole body)
Primary outcome measures
- Uptake of radiolabelled siderophore (68Ga-TAFC) in patients with proven/probable invasive Aspergillosis [Time frame: At 60 minutes]
Secondary outcome measures (3)
- Physiologic bio distribution [Time frame: Evaluated up to 3 hours following injection of radiotracer]
- Safety of 68Ga-TAFC-PET/CT [Time frame: Evaluated within 24 hours of scan]
- Findings compared to CT and/or 18F-FDG PET/CT [Time frame: At 60 minutes]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Australia · 1 center
- Peter MacCallum Cancer Centre — Melbourne
Identifiers
NCT: NCT06105411 · SPECIFIC