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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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• An illness of more than 3 weeks' duration,

• Temperature exceeding 38.3°C on \> 3 occasions, or elevated inflammatory markers on \> 3 occasions

• Diagnosis uncertain despite appropriate first-line investigations.

• High clinical suspicion of IgG4-RD by an experienced clinician of Internal Medicine, based on anamnesis, physical examination, first-line investigations and blood tests.

• Patients with a new diagnosis of IgG4-RD on histopathology and need for further assessment of disease extent with PET/CT,

• Relapse of diagnosed IgG4-RD on histopathology according to an experienced clinician of Internal Medicine

• High clinical suspicion of axial spondyloarthropahy according to an experienced rheumatology (based on inflammary back pain \> 3 months, insidious onset, morning stifness, improvement with exercise and worsening in rest, pain worse at night, age at onset \<45 years of age, imaging findings).

• Patient has persisting inflammatory back pain after 2 different types of NSAID's (tried for over 2-4 weeks), and is therefore eligible for biological DMARDS therapy.

Locations
Other Locations
Belgium
University Hospital Leuven
RECRUITING
Leuven
Contact Information
Primary
Lennert Boeckxstaens, MD
lennert.boeckxstaens@uzleuven.be
+0032 16 34 37 15
Time Frame
Start Date: 2025-09-17
Estimated Completion Date: 2030-03-31
Participants
Target number of participants: 140
Treatments
Experimental: FUO/IUO
Experimental: IgG4-related disease
Experimental: Axial Spondyloarthritis
Related Therapeutic Areas
IgG4-Related Disease
Arthritis
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov

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