Orbital blood-vessel inflammation in giant cell arteritis and ischemic optic neuropathy
Orbital Vascular Inflammation in Ischemic Optic Neuropathy and Giant Cell Arteritis
This project will test whether advanced FDG PET/MRI with black-blood sequences plus OCT scans can tell if sudden optic nerve damage is due to giant cell arteritis or non-arteritic ischemic optic neuropathy in people aged 50 and older.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 122 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Glostrup Municipality) |
| Trial ID | NCT07206238 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 50 or older with newly onset signs of ischemic optic neuropathy (papilledema, visual loss, or RAPD) or with newly diagnosed, ultrasound-confirmed GCA without visual changes are potential candidates.
Not a fit: People with ferromagnetic implants, severe renal impairment (eGFR <30), MRI-contrast allergy, severe claustrophobia, pregnancy or breastfeeding, prior ipsilateral optic neuropathy/GCA, or more than five days of prednisolone before enrollment are likely ineligible and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the imaging approach could enable faster, more accurate diagnosis so people with GCA get prompt steroid treatment while sparing others unnecessary steroid exposure.
How similar studies have performed: FDG PET has previously shown vascular inflammation in large- and medium-sized arteries in GCA, but applying orbital PET/MRI black-blood sequences together with OCT to distinguish A-AION from NAION is relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Glostrup Municipality
- Rigshospitalet - Glostrup — Glostrup Municipality, Denmark (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.