University Hospital Leuven
Leuven, 3000, Belgium
Location status: Recruiting
NCT Number: NCT07535554
The aim of the study to evaluate the performance of new [18F]-AlF-FAPI-74 PET/CT in three inflammatory disorders (fever of unknown origin, IgG4-related disease and axial spondyloarthritis) and compare with the current stand-of-care [18F]-FDG PET/CT
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Leuven, 3000, Belgium
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
FUO:
Inclusion criteria
IgG4-RD:
Inclusion criteria
AxSpA:
Exclusion criteria
A [18F]AlF-FAPI-74 PET/CT will be performed at the same site of the screening visit (UZ Leuven). The patient will get an IV line, through which the [18F]AlF-FAPI-74 will be injected in one bolus (3,5 MBq/kg). After 60 minutes, the acquisition on the PET/CT scan will take place. The CT will be a low dose CT with oral contrast. After the scan, participants will be observed at the department in case of adverse events. If the patient receives therapy (for IgG4-RD and AxSpA), a second [18F]AlF-FAPI-74 PET/CT will be performed three months later.
Time frame: 6 months after completion of both PET/CT scans
Time frame: After completion of both PET/CT scans before initiation of treatment and after completion of both PET/CT scans 3 months completion of treatment.
Time frame: After completion of first PET/CT scan and after completion of PET/CT scan performed 3 months after treatment
Time frame: 6 months after completion of all PET/CT scans
Time frame: 6 months after completion of all PET/CT scans
Time frame: 6 months after completion of all PET/CT scans
Time frame: After completion of both PET/CT scans before initiation of treatment and after completion of both PET/CT scans 3 months completion of treatment.
Time frame: After completion of both PET/CT scans before initiation of treatment and after completion of both PET/CT scans 3 months completion of treatment.
Time frame: After completion of both PET/CT scans before initiation of treatment and after completion of both PET/CT scans 3 months completion of treatment.
Time frame: After completion of both PET/CT scans before initiation of treatment and after completion of both PET/CT scans 3 months completion of treatment.
Time frame: After completion of first PET/CT scan and after completion of PET/CT scan performed 3 months after treatment
Time frame: After completion of first PET/CT scan and after completion of PET/CT scan performed 3 months after treatment
Time frame: After completion of first PET/CT scan and after completion of PET/CT scan performed 3 months after treatment
Contact information is provided by the study sponsor or research team.
Universitaire Ziekenhuizen KU Leuven
Other
Prospective Diagnostic Performance of PET/CT Using the Novel Fibroblast Imaging Tracer [18F]-AlF-FAPI-74 Versus Standard of Care [18F]-FDG in Inflammatory Disorders
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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