Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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:
Invasive Fungal Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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)
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Uptake of radiolabelled siderophore (68Ga-TAFC) in patients with proven/probable invasive Aspergillosis
Timepoint [1] 0 0
At 60 minutes
Secondary outcome [1] 0 0
Physiologic bio distribution
Timepoint [1] 0 0
Evaluated up to 3 hours following injection of radiotracer
Secondary outcome [2] 0 0
Safety of 68Ga-TAFC-PET/CT
Timepoint [2] 0 0
Evaluated within 24 hours of scan
Secondary outcome [3] 0 0
Findings compared to CT and/or 18F-FDG PET/CT
Timepoint [3] 0 0
At 60 minutes

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)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne

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/ct2/show/NCT06105411
Trial related presentations / publications
Public notes

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
Abby.Douglas@petermac.org
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06105411