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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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:
Condition category
Condition code
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
Experimental: IBI3003 -
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Comparator / control treatment
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Control group
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Outcomes
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)
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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/study/NCT06105411
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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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
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06105411
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