Actively Recruiting

Age: 18Years +
All Genders
ID06105411

Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal Infections

Led by Peter MacCallum Cancer Centre, Australia · Updated on 2025-09-05

10

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new imaging technique to detect invasive Aspergillus fungal infections using a radiolabelled fungal component called a siderophore. This open-label, single-center pilot study aims to show how a gallium-siderophore tracer accumulates in areas of proven or probable invasive fungal infection. The study will also assess how safe and tolerable this imaging method is for patients. Participants will receive a whole-body PET/CT scan using the 68Ga-labelled TAFC tracer. The study plans to recruit 10 patients diagnosed within the last two weeks with proven or probable invasive fungal infection. The imaging will be done to observe uptake of the tracer at infection sites, with follow-up assessments scheduled over the study period. During the study, patients will undergo PET/CT scans and have their physiological biodistribution evaluated up to three hours after injection of the radiotracer. Safety assessments will be made within 24 hours after the scan. The imaging findings will also be compared to standard CT and FDG-PET/CT scans. Participants will be monitored according to the study protocol, including scheduled visits and follow-up to assess outcomes.

CONDITIONS

Brief Title

Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient has provided written informed consent
  • Aged 18 years or older at written informed consent
  • Within 2 weeks of proven, probable, or possible invasive fungal infection 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
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Up to 3 hours on scan day

Participants undergo a 68Ga-labelled TAFC PET/CT scan to evaluate uptake of the radiolabelled siderophore and assess safety and bio distribution.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 24 hours after scan

Participants are observed for safety and tolerability following the imaging procedure.

Trial Site Locations

Total: 1 location

1

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia, 3000

Actively Recruiting

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Research Team

A

Abby Douglas

B

Beatrice Sim

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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