FALCON-GCA
Research type
Research Study
Full title
Feasibility Assessment Leveraging Cranial Vessel Wall and Orbital Neuroimaging in GCA
IRAS ID
347780
Contact name
Sarah Mackie
Contact email
Sponsor organisation
‘University of Leeds
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 6 months, 15 days
Research summary
Background:
Giant cell arteritis (GCA) is a rare condition that can cause permanent vision loss. It is difficult to predict which patients presenting with GCA will develop visual complications. Recent studies suggest that MRI of the eye area (orbital MRI) can detect early eye involvement in GCA.
Aim:
To conduct a feasibility study examining the integration of MRI of the eye and head as a research test within an existing NHS GCA diagnostic pathway.
Build on existing MRI protocols to assess image quality, inter-rater reliability, and validate MRI scoring systems.
Evaluate the feasibility of adding US tests and compare results with MRI and symptoms.
Collect data on self-recording steroid dosages and standardise symptom tracking using a checklist.Method:
We will recruit consecutive patients with suspected GCA, identified via the Leeds GCA Pathway. Consenting patients with a positive diagnostic test, with temporal artery ultrasound will undergo ultrasound of the blood vessel that supplies the jaw (maxillary artery) and off the eye (optic nerve and sheath). A symptoms checklist will be completed. Clinical assessment of the eyes will be done, along with the chewing gum test (as a measure of jaw pain). Any patients experiencing visual symptoms will be referred to eye casualty as per standard of care. Outcome of this referral will be recorded.
Participants will undergo a combined MRI off their head and eyes. Recruitment will continue, until we have successfully performed MRI on 10 consenting patients.
Participants will be followed up over a 3-month period, with a telephone follow-up call at 2 weeks and 3 months. In addition, verbal feedback will be gathered from the participants at 3-month, to understand participant acceptability of protocol and procedures.
Outcomes:
We’ll assess how feasible this study design is, to determine if larger clinical trials can be run in the future.
REC name
London - South East Research Ethics Committee
REC reference
25/PR/1234
Date of REC Opinion
10 Sep 2025
REC opinion
Favourable Opinion