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A novel fibroblast imaging biomarker and ultrahigh resolution PET to improve the diagnosis and follow-up of giant cell arteritis
EU CTIS ID: 2025-523880-39-02
What this study is testing
1. Demonstrate the ability of NX PET/CT to assess active arteritis of the ophthalmic artery. 2. Demonstrate that the diagnostic performance of FAPI PET/CT is at least equivalent to the current gold standard, FDG PET (non-inferiority study with non-inferiority limit 15%). 3. Demonstrate the ability of FAPI PET/CT to identify chronic pathological fibroblast activation. 4. To unravel the role of FAP in the pathogenesis of GCA using single nuclei RNA sequencing on temporal artery biopsies, obtained from patients with GCA. 5. Primary objectives UHR NeuroEXPLORER PET : see Master Protocol EUDAMED_ CIV-25-06-053398
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants eligible for inclusion in this Trial must meet all of the following criteria: - Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures - At least 18 years of age at the time of signing the Informed Consent Form (ICF) - Female subjects should be (a) post-menopausal, or (b) surgically sterile, or (c) using effective contraceptive with negative pregnancy test. - Patients with a high clinical suspicion of GCA according to a clinical physician with ample experience. - 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.
You likely can't join 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.