Orbital blood-vessel inflammation in giant cell arteritis and ischemic optic neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational imaging project will recruit people aged 50 or older with newly suspected ischemic optic neuropathy and a separate group with newly diagnosed giant cell arteritis without visual symptoms. Participants will undergo FDG PET/MRI using black-blood sequences to look for inflammation in orbital and peri-orbital vessels, and optical coherence tomography (OCT) to identify subtle retinal biomarkers. The investigators will compare imaging patterns between arteritic and non-arteritic cases to find markers that distinguish the two conditions. The goal is to improve diagnostic accuracy and to deepen understanding of vascular changes that cause ischemic optic neuropathy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

For AION group:

* Clinical suspicion of newly onset ischemic optic neuropathy (A-AION or NA-AION), defined by ipsilateral findings of: Papilledema; Relevant visual impairment measured by visual acuity and/or visual field; Relative afferent pupillary defect (RAPD), except if mydriatic agents have been administered or if bilateral optic neuropathy is present.
* Age ≥ 50 years

For GCA group:

* Clinically- and ultrasound-confirmed, newly diagnosed GCA
* Absence of visual changes related to GCA in one or both eyes, including: Transient vision loss; permanent vision loss; transient double vision; permanent double vision
* Age ≥ 50 years

Exclusion Criteria:

* Ferromagnetic implants
* Severe renal impairment with eGFR \< 30 mL/min/1.73m²
* Allergy to MRI contrast agents
* Severe claustrophobia
* Pregnancy or breastfeeding
* Previously documented ipsilateral optic neuropathy or giant cell arteritis
* More than 5 days of treatment with prednisolone prior to inclusion

Where it's running

• Rigshospitalet - Glostrup
  Glostrup Municipality, Denmark Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.