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Phase 2 FAPI-74 PET/CT Inflammatory Disorders Study

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Summary

NIH registered Phase 2 clinical trial NCT07535554 to evaluate [18F]-AlF-FAPI-74 PET/CT diagnostic performance in three inflammatory disorder cohorts: fever of unknown origin, IgG4-related disease, and axial spondyloarthritis. The study will compare the new radiopharmaceutical against standard-of-care [18F]-FDG PET/CT imaging.

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What changed

NIH registered a new Phase 2 clinical trial (NCT07535554) on ClinicalTrials.gov studying [18F]-AlF-FAPI-74 PET/CT imaging in inflammatory disorders. The study will enroll patients with fever of unknown origin, IgG4-related disease, and axial spondyloarthritis, comparing the investigational radiopharmaceutical against standard [18F]-FDG PET/CT.

Healthcare providers and clinical investigators may encounter this new diagnostic imaging agent in future patient care settings. Pharmaceutical and medical device manufacturers involved in radiopharmaceutical development should note this competitive evaluation of novel PET tracers targeting fibroblast activation protein.

Archived snapshot

Apr 17, 2026

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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.

Phase 2 NCT07535554 Kind: PHASE2 Apr 17, 2026

Abstract

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: Fever of Unknown Origin, IgG4 Related Disease, Axial Spondylarthritis (axSpA), Inflammation of Unknown Origin

Interventions: [18F]AlF-FAPI-74 PET/CT

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Abstract Conditions Interventions

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Last updated

Classification

Agency
NIH
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07535554

Who this affects

Applies to
Clinical investigators Healthcare providers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trial registration Diagnostic imaging Radiopharmaceutical research
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Topics
Healthcare Medical Devices

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