Invasive Fungal InfectionsSPECIFICNCT06105411
Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions
An observational study of Invasive Fungal Infections, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
Trial summary
This trial will demonstrate localised uptake of a radiolabelled fungal component (siderophore) in areas of known specific invasive fungal (Aspergillus) infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Fungal Infections
- What is being tested?
- 68Ga-labelled TAFC PET/CT scan
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Dec 2023to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Women who are pregnant or lactating.
- Iron infusion within one week prior to scan
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Beatrice Sim contact
Australia1 site, 1 recruiting
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Abby Douglas, 855 96136, Abby.Douglas@petermac.org
Beatrice Sim, Beatrice.Sim@petermac.org
About this study
This trial will demonstrate localised uptake of a radiolabelled fungal component (siderophore) in areas of known specific invasive fungal (Aspergillus) infection.
Read the 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.
- Conditions
- Invasive Fungal Infections
- Being tested
- 68Ga-labelled TAFC PET/CT scan
- Keywords
- Invasive Fungal Infections, Siderophore, PET, Siderophore-labelled Position Emission tomography, 68Ga-labelled TAFC PET/CT scan, Aspergillus spp.
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-labelled TAFC PET/CT scanDiagnostic test
68Ga-labelled TAFC PET/CT scan (whole body)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 60 minutes
Secondary outcomes (3)
Physiologic bio distribution
SUVmax in mediastinal blood pool, and any organs with uptake including liver, spleen and marrow
Measured: Evaluated up to 3 hours following injection of radiotracer
Safety of 68Ga-TAFC-PET/CT
Adverse events defined by CTCAE v5
Measured: Evaluated within 24 hours of scan
Findings compared to CT and/or 18F-FDG PET/CT
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
Measured: At 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Dec 2023
- Primary completionOct 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105411
- Sponsor's protocol ID
- SPECIFIC
- Acronym
- SPECIFIC
- Status last verified
- Aug 2025
- First submitted
- 12 Oct 2023
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions
- ClinicalTrials.gov ID
- NCT06105411
- Acronym / sponsor ID
- SPECIFIC / SPECIFIC
- Conditions
- Invasive Fungal Infections
- Keywords
- Invasive Fungal Infections, Siderophore, PET, Siderophore-labelled Position Emission tomography, 68Ga-labelled TAFC PET/CT scan, Aspergillus spp.
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Women who are pregnant or lactating.
- Iron infusion within one week prior to scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-labelled TAFC PET/CT scan68Ga-labelled TAFC PET/CT scan (whole body) | Diagnostic test | – |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beatrice Sim contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Fungal Infections, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abby Douglas (03 855 96136, Abby.Douglas@petermac.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of radiolabelled siderophore (68Ga-TAFC) in patients with proven/probable invasive Aspergillosis (time frame: At 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.