Actively Recruiting
The Investigators Will Evaluate the Diagnostic Performance of [18F]-AlF-FAPI-74 PET/CT in Inflammatory Disorders and Compare it With the Current Gold Standard for Inflammation, FDG PET/CT, in Three Patient Cohort: Patients Presenting With Fever of Unknown Origin, IgG4-RD and AxSpA.
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-04-17
140
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
The Investigators Will Evaluate the Diagnostic Performance of [18F]-AlF-FAPI-74 PET/CT in Inflammatory Disorders and Compare it With the Current Gold Standard for Inflammation, FDG PET/CT, in Three Patient Cohort: Patients Presenting With Fever of Unknown Origin, IgG4-RD and AxSpA.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Illness lasting more than 3 weeks with fever over 38.3 0C on more than 3 occasions or elevated inflammatory markers on more than 3 occasions with uncertain diagnosis after first-line tests
- High clinical suspicion of IgG4-related disease by an internal medicine specialist
- New diagnosis of IgG4-related disease confirmed by biopsy needing disease extent assessment
- Relapse of biopsy-confirmed IgG4-related disease as assessed by an experienced clinician
- High clinical suspicion of axial spondyloarthritis based on inflammatory back pain symptoms lasting over 3 months and typical features
- Persistent inflammatory back pain after trying two different NSAIDs for 2 to 4 weeks, making patient eligible for biological DMARDs therapy
You will not qualify if you...
- Mentally or legally incapacitated, unable or unwilling to undergo all study procedures
- Any condition that could risk participant safety or study compliance as judged by the investigator
- Prior or current treatments that could endanger safety or affect study integrity
- Pregnant or breastfeeding females, or females of childbearing potential not using highly effective contraception
- Participation in an incompatible interventional trial involving investigational drugs or devices
- Participation in a study with radiation exposure over 1 mSv in the past 12 months
- Known hypersensitivity to [18F]AlF-FAPI-74 or its components
- Already started active treatment for the studied condition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
L
Lennert Boeckxstaens, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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