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A novel fibroblast imaging biomarker and ultrahigh resolution PET to improve the diagnosis and follow-up of giant cell arteritis

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523880-39-02
Enrollment
60
Registered
2026-02-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant Cell Arteritis

Brief summary

Ability to visualize activate arteritis of the ophthalmic artery. Diagnostic accuracy (AUC – combined sensitivity and specifity) of FDG and FAPI PET for diagnosing GCA. Ability to visualize to identify chronic pathological fibroblast activation on FAPI PET. Demontsrate a correlation between FAP+ fibroblast cell state and FAPI PET parameters at clinical diagnosis and remission. Additional primary endpoints related to the clinical investigational NeuroEXPLORER device : See Master Protocol

Detailed description

To distinguish GCA from non-GCA causes in patients presenting with vision loss. . To evaluate the evolution of FAPI and FDG uptake from active disease to remission. To identify other import cell types in the pathogenesis of GCA using single nuclei RNA sequencing. Additional secondary endpoints related to the clinical investigational NeuroEXPLORER device: See Master Protocol EUDAMED_ CIV-25-06-053398.

Interventions

None listed

Sponsors

UZ Leuven
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Ability to visualize activate arteritis of the ophthalmic artery. Diagnostic accuracy (AUC – combined sensitivity and specifity) of FDG and FAPI PET for diagnosing GCA. Ability to visualize to identify chronic pathological fibroblast activation on FAPI PET. Demontsrate a correlation between FAP+ fibroblast cell state and FAPI PET parameters at clinical diagnosis and remission. Additional primary endpoints related to the clinical investigational NeuroEXPLORER device : See Master Protocol—

Secondary

MeasureTime frame
To distinguish GCA from non-GCA causes in patients presenting with vision loss. . To evaluate the evolution of FAPI and FDG uptake from active disease to remission. To identify other import cell types in the pathogenesis of GCA using single nuclei RNA sequencing. Additional secondary endpoints related to the clinical investigational NeuroEXPLORER device: See Master Protocol EUDAMED_ CIV-25-06-053398.—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 10, 2026