Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions
SPECIFIC
1 other identifier
observational
10
1 country
1
Brief Summary
This trial will demonstrate localised uptake of a radiolabelled fungal component (siderophore) in areas of known specific invasive fungal (Aspergillus) infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2023
CompletedFirst Posted
Study publicly available on registry
October 27, 2023
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
September 5, 2025
August 1, 2025
2.8 years
October 12, 2023
August 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Physiologic bio distribution
Evaluated up to 3 hours following injection of radiotracer
Safety of 68Ga-TAFC-PET/CT
Evaluated within 24 hours of scan
Findings compared to CT and/or 18F-FDG PET/CT
At 60 minutes
Interventions
68Ga-labelled TAFC PET/CT scan (whole body)
Eligibility Criteria
Patients aged 18 years or older at written informed consent who have proven or probable invasive fungal infection (IFI) diagnosis with imaging consistent with invasive pulmonary aspergillosis on CT or FDG-PET/CT with lesions at least 8mm in diameter. They are also willing and able to comply with the protocol for the duration of the study including scheduled visits such as follow up.
You may qualify if:
- 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
You may not qualify if:
- Women who are pregnant or lactating.
- Iron infusion within one week prior to scan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2023
First Posted
October 27, 2023
Study Start
December 1, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
September 5, 2025
Record last verified: 2025-08