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Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

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.

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

Participants eligible for this Investigation must not meet any of the following criteria: - 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. - Participant is mentally or legally incapacitated, doesn’t understand the study design or is not willing or capable to undergo all study-specific procedures. - Any disorder or condition, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol. - Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial. - 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). - 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. - Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv. - Participant has a known hypersensitivity to [ 18F]AlF-FAPI-74 or the used excipients

Source record

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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

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Registry identifier

2025-523880-39-02

Data provider

European Medicines Agency (EMA)

Normalization version

ctis-v1

Source retrieved: 2026-10-31 06:37:39 UTC

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

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Sponsors & Collaborators

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Central Study Contacts

Study Design

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Source record

Documents

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Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

Locations