Actively Recruiting
Orbital Vascular Inflammation in Ischemic Optic Neuropathy and Giant Cell Arteritis
Led by Rigshospitalet, Denmark · Updated on 2026-05-07
122
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Giant cell arteritis (GCA) is an inflammation of the blood vessels. A dangerous complication is sudden vision loss due to insufficient blood supply to the optic nerve. However, it is often difficult to distinguish acute vision loss due to GCA from a similar condition of insufficient blood supply to the optic nerve, called NAION. Quick treatment with anti-inflammatory medication is needed in case of GCA to prevent vision loss on the eye and other serious complications. Patients with NAION have no benefit of the medication, but can have serious side effects, why it is very important to differentiate between these conditions. In this project, the investigators will use FDG PET/MRI with Black Blood (BB) sequences and OCT-imaging to study patients with GCA and/or ischemic optic nerve disease. The investigators will look for signs of inflammation in and around the small vessels of the orbit using PET/MRI and study subtle retinal changes using OCT images. The investigators want to answer the following research questions: Do patients with ischemic optic nerve disease and GCA show signs of inflammation in the orbital vessel wall on PET/MRI-scans, that are not present in patients with NAION? Do GCA patients without vision loss, but with signs of orbital vessel wall inflammation on PET/MRI-scans, have a higher risk of later vision loss than GCA patients without? Can subtle changes in the retina, detectable through OCT, help distinguish between GCA-related vision loss and NAION? This will, to our knowledge, be the first study to systematically use FDG PET/MRI BB-scans to illuminate vascular changes in the orbit of patients with GCA and/or ischemic optic nerve disease. The results may improve diagnosis and treatment of GCA and NAION in the future. The investigators hope that this will help prevent blindness and other serious complications in patients with GCA, while also avoiding unnecessary treatments for patients with NAION.
CONDITIONS
Official Title
Orbital Vascular Inflammation in Ischemic Optic Neuropathy and Giant Cell Arteritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical suspicion of newly onset ischemic optic neuropathy (A-AION or NA-AION) with signs such as papilledema, visual impairment, or relative afferent pupillary defect
- Age 50 years or older
- Clinically and ultrasound-confirmed newly diagnosed giant cell arteritis without visual changes such as transient or permanent vision loss or double vision
- Age 50 years or older
You will not qualify if you...
- Presence of ferromagnetic implants
- Severe renal impairment with eGFR less than 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Rigshospitalet - Glostrup
Glostrup Municipality, Denmark, 2600
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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