Trial Review

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These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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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
Scientific title
Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions
Secondary ID [1] 0 0
SPECIFIC
Universal Trial Number (UTN)
Trial acronym
SPECIFIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Experimental: IBI3003 -

Comparator / control treatment
Control group

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women who are pregnant or lactating.
2. Iron infusion within one week prior to scan

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This trial will demonstrate localised uptake of a radiolabelled fungal component (siderophore) in areas of known specific invasive fungal (Aspergillus) infection.
Trial website
https://clinicaltrials.gov/study/NCT06105411
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Abby Douglas
Address 0 0
Country 0 0
Phone 0 0
03 855 96136
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06105411