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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06105411
Registration number
NCT06105411
Ethics application status
Date submitted
12/10/2023
Date registered
27/10/2023
Date last updated
18/03/2024
Titles & IDs
Public title
Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions
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Scientific title
Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions
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Secondary ID [1]
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SPECIFIC
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Universal Trial Number (UTN)
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Trial acronym
SPECIFIC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Invasive Fungal Infections
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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0
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Sexually transmitted infections
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Diagnosis / Prognosis - 68Ga-labelled TAFC PET/CT scan
Diagnosis / Prognosis: 68Ga-labelled TAFC PET/CT scan
68Ga-labelled TAFC PET/CT scan (whole body)
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Uptake of radiolabelled siderophore (68Ga-TAFC) in patients with proven/probable invasive Aspergillosis
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Assessment method [1]
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The maximum standardized uptake value (SUVmax) is widely used for measuring the uptake of FDG by malignant tissue.
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Timepoint [1]
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At 60 minutes
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Secondary outcome [1]
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Physiologic bio distribution
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Assessment method [1]
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SUVmax in mediastinal blood pool, and any organs with uptake including liver, spleen and marrow
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Timepoint [1]
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Evaluated up to 3 hours following injection of radiotracer
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Secondary outcome [2]
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Safety of 68Ga-TAFC-PET/CT
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Assessment method [2]
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Adverse events defined by CTCAE v5
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Timepoint [2]
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Evaluated within 24 hours of scan
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Secondary outcome [3]
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Findings compared to CT and/or 18F-FDG PET/CT
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Assessment method [3]
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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
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Timepoint [3]
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At 60 minutes
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Eligibility
Key inclusion criteria
1. Patient has provided written informed consent
2. Aged 18 years or older at written informed consent
3. Within 2 weeks of proven or probable invasive fungal infection (IFI) diagnosis as per
EORTC criteria
4. Imaging consistent with invasive pulmonary aspergillosis on CT or FDG-PET/CT with
lesions at least 8mm in diameter
5. Patient is willing and able to comply with the protocol for the duration of the study
including scheduled visits such as follow up
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Women who are pregnant or lactating.
2. Iron infusion within one week prior to scan
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2026
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Peter MacCallum Cancer Centre, Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This trial will demonstrate localised uptake of a radiolabelled fungal component
(siderophore) in areas of known specific invasive fungal (Aspergillus) infection.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06105411
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Abby Douglas
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Address
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Country
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Phone
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03 855 96136
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06105411
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