How MRI spatial resolution affects detection of giant cell arteritis
Impact of the Spatial Resolution of Several Contrast-enhanced 3D T1-WI Sequences When Diagnosing Giant Cell Arteritis (GCA)
This project will test whether different contrast-enhanced 3D T1 MRI sequences with varied spatial resolution better detect giant cell arteritis in adults who are suspected of having it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 133 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Drugs / interventions | prednisone |
| Locations | 1 site (Paris) |
| Trial ID | NCT05854927 on ClinicalTrials.gov |
What this trial studies
This observational imaging study compares several contrast-enhanced 3D T1-weighted MRI sequences (with fat saturation and black-blood technique) acquired at different spatial resolutions in adults referred for suspected giant cell arteritis. Patients undergo the routine injected MRI and images from each sequence are reviewed for vessel wall thickening, enhancement, and overall image quality. Diagnostic performance of the sequences will be compared against the referring clinician’s final diagnosis and available reference tests (clinical follow-up and/or biopsy when performed). The goal is to determine which spatial resolution provides the best balance of diagnostic accuracy and image quality in real-world practice.
Who should consider this trial
Good fit: Adults (over 18) referred for contrast-enhanced MRI because of suspected giant cell arteritis who meet the clinical suspicion criteria and consent to participate are ideal candidates.
Not a fit: Patients with contraindications to MRI or contrast, those without clinical suspicion of GCA, or those with conditions excluded by the protocol (for example recent newly diagnosed malignancy) are unlikely to benefit from this imaging comparison.
Why it matters
Potential benefit: If successful, the findings could help radiologists pick MRI settings that improve noninvasive diagnosis of giant cell arteritis and reduce the need for invasive biopsy or delayed treatment.
How similar studies have performed: Previous work has shown temporal artery MRI, especially contrast-enhanced 3D black-blood sequences, can have high sensitivity and specificity for GCA, but optimal spatial resolution parameters remain to be clarified.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient over 18 years of age * Referred for imaging for an injected MRI for suspected GCA * Suspicion of GCA based on the presence of three major criteria or two major and one minor criteria defined as follows: * Major criteria: Age \> 50 years; Headache of recent onset; Claudication of the jaw, tongue or swallowing disorders; Visual problems (blindness, diplopia, blurred vision - including visual accidents occurring during the first week of treatment); Sedimentation rate at 1st hour \> 50 and/or CRP \> 8mg/l * Minor criteria: Hypersensitivity or induration of the scalp or presence of nodules remote from the temporal artery; Temporal artery abnormalities on palpation; Facial pain or feeling of facial edema; General signs (fever \>38°C, weight loss \>10%, anorexia, malaise, asthenia). * Cconsent to participate in the study * Affiliated or beneficiary of a social security plan Exclusion Criteria: * Newly diagnosed malignant disease (diagnosed less than one year prior to inclusion) * Active infectious disease * Autoimmune disease (especially but not limited to: Wegener's disease, Takayasu vasculitis, ANCA vasculitis, rheumatoid arthritis, lupus erythematosus, periarteritis nodosa). * Systemic corticosteroid therapy for more than 10 days at high dose (\>0.5mg/kg/d of prednisone) * Contraindication to MRI * Patient benefiting from a legal protection measure * Pregnant or breastfeeding woman
Where this trial is running
Paris
- Hôpital Fondation Adolphe de Rothschild — Paris, France (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.