[AL[18F]F]FAPI-74 for Giant cell arteritis

Inclusion criteria

• {"criterion_text":"- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures"}
• {"criterion_text":"- At least 18 years of age at the time of signing the Informed Consent Form (ICF)"}
• {"criterion_text":"- Female subjects should be (a) post-menopausal, or (b) surgically sterile, or (c) using effective contraceptive with negative pregnancy test."}
• {"criterion_text":"- Patients with a high clinical suspicion of GCA according to a clinical physician with ample experience."}
• {"criterion_text":"- Treatment with glucocorticosteroids has not commenced. However, if urgent ischemic symptoms arise, treatment with glucocorticoids will be initiated and both PET/CT scans will be performed within the first 3 days of therapy."}

Exclusion criteria

• {"criterion_text":"- Treatment with oral glucocorticoids already commenced. However, if urgent ischemic symptoms arise, treatment with glucocorticoids will be initiated and both PET/CT scans will be performed within the first 3 days of therapy."}
• {"criterion_text":"- Participant is mentally or legally incapacitated, doesn’t understand the study design or is not willing or capable to undergo all study-specific procedures."}
• {"criterion_text":"- Any disorder or condition, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol."}
• {"criterion_text":"- Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial."}
• {"criterion_text":"- Female who is pregnant (urinary hCG test will be performed in every WOCBP), breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive (with a relatively high Pearl Index: natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active are not accepted)."}
• {"criterion_text":"- Participation in an interventional Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team."}
• {"criterion_text":"- Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv."}
• {"criterion_text":"- Participant has a known hypersensitivity to [ 18F]AlF-FAPI-74 or the used excipients"}

Primary endpoints

• {"endpoint_text":"- Ability to visualize activate arteritis of the ophthalmic artery.\n- Diagnostic accuracy (AUC – combined sensitivity and specifity) of FDG and FAPI PET for diagnosing GCA.\n- Ability to visualize to identify chronic pathological fibroblast activation on FAPI PET.\n- Demontsrate a correlation between FAP+ fibroblast cell state and FAPI PET parameters at clinical diagnosis and remission.\n- Additional primary endpoints related to the clinical investigational NeuroEXPLORER device : See Master Protocol","definition_or_measurement_approach":"Ability to visualize ophthalmic artery arteritis: assessed by NX PET/CT imaging (visualization on PET/CT). Diagnostic accuracy: measured by AUC (combined sensitivity and specificity) comparing FDG and FAPI PET for diagnosing GCA. Visualization of chronic pathological fibroblast activation: assessed by FAPI PET imaging. Correlation endpoint: correlation between FAP+ fibroblast cell state (from temporal artery biopsies / single-nucleus RNA sequencing) and FAPI PET quantitative parameters. Additional device-related primary endpoints: referenced to Master Protocol."}

Secondary endpoints

• {"endpoint_text":"- To distinguish GCA from non-GCA causes in patients presenting with vision loss.\n- To evaluate the evolution of FAPI and FDG uptake from active disease to remission.\n- To identify other import cell types in the pathogenesis of GCA using single nuclei RNA sequencing.\n- Additional secondary endpoints related to the clinical investigational NeuroEXPLORER device: See Master Protocol EUDAMED_ CIV-25-06-053398.","definition_or_measurement_approach":"Distinguish GCA from non-GCA causes: diagnostic imaging comparison in patients with vision loss. Evolution of uptake: longitudinal imaging assessment of FAPI and FDG uptake between active disease and remission (quantitative uptake measures). Identification of cell types: single-nucleus RNA sequencing of temporal artery biopsies to define cell populations. Additional device-related secondary endpoints: see Master Protocol."}

Belgium

Earliest CTIS Part Ii Submission Date

04-02-2026

Latest Decision Or Authorization Date

09-02-2026

Processing Time Days

5

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium