Diagnostic Accuracy of FDG PET/CT of Cranial Arteries in GCA
- Conditions
- Giant Cell Arteritis
- Interventions
- Radiation: FDG PET/CT
- Registration Number
- NCT03409913
- Lead Sponsor
- University of Aarhus
- Brief Summary
A case-control study to evaluate the diagnostic accuracy of FDG uptake in cranial arteries by FDG PET/CT in the diagnosis of giant cell arteritis.
- Detailed Description
Although older studies argue that FDG PET/CT cannot demonstrate inflammation in cranial arteries, e.g. temporal and maxillary arteries, the resolution of modern PET systems may have improved, making a case for FDG PET/CT. FDG PET/CT is increasingly used in giant cell arteritis (GCA) diagnosis due to its excellent diagnostic accuracy considering large-vessel involvement. In case of uncommon distribution of vessel involvement or marginally increased large-vessel FDG uptake, FDG PET/CT-specificity may be compromised. Hence, recognising FDG uptake in cranial arteries potentially adds to FDG PET/CTs diagnostic accuracy.
Objectives To evaluate the diagnostic accuracy of conventional FDG PET/CT of the cranial arteries in the diagnosis of GCA.
Methods In a cohort of consecutively included glucocorticoid-naïve patients suspected of new-onset GCA, patients with a clinical GCA diagnosis will be identified. Conventional FDG PET/CT and vascular ultrasound(US) was performed before treatment. Patients were referred for a temporal artery biopsy (TAB).
Controls are age-(+/- 3 years) and sex-matched malignant melanoma (MM) patients who had a follow-up metastatic-disease-free FDG PET/CT ≥6 months after MM resection.
Images will be assessed by 5 nuclear medicine physicians blinded to clinical symptoms and findings. Temporal (TA), maxillary (MA) and vertebral (VA) arteries will be visually assessed. Arterial FDG uptake more than FDG uptake in surrounding tissue is considered positive. Sensitivity, specificity and interreader agreement will be evaluated.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
Cases:
-
- age ≥50 years, 2) CRP>15mg/l or ESR>40mm/h, 3) either a) cranial symptoms, b) new-onset extremity claudication or c) weight loss >5 kilograms or fever>38oC for >3 weeks and a clinical diagnosis of giant cell arteritis judged by expert rheumatologist.
Controls:
- age-(+/-3 years) and sex-matched malignant melanoma (MM) patients
- follow-up metastatic-disease-free FDG PET/CT ≥6 months after MM resection
- Previous diagnosis of polymyalgia or giant cell arteritis
- immunosuppresive treatment within last month
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description controls FDG PET/CT Age-(+/- 3 years) and sex-matched malignant melanoma (MM) patients who had a follow-up metastatic-disease-free FDG PET/CT ≥6 months after MM resection GCA cases FDG PET/CT In a cohort of patients suspected of GCA based on the following inclusion criteria were 1) age ≥50 years, 2) CRP\>15mg/l or ESR\>40mm/h, 3) either a) cranial symptoms, b) new-onset extremity claudication or c) weight loss \>5 kilograms or fever\>38oC for \>3 weeks, patients with a clinical diagnosis of GCA is identified.
- Primary Outcome Measures
Name Time Method PET positivity Time of diagnosis/pre-treatment (cases) Presence of FDG uptake in temporal, maxillary and/or vertebral arteries assessed in order to evaluate sensitivity and specificity of PET of cranial arteries in the diagnosis of GCA
- Secondary Outcome Measures
Name Time Method Full-fillment of ACR criteria Time of diagnosis PET sensitivity and specificity in the subpopulation of GCA patients full filling ACR criteria
Temporal artery biopsy Time of diagnosis Correlation between temporal artery biopsy result and temporal artery FDG uptake
Temporal artery ultrasound Time of diagnosis Correlation between temporal artery ultrasound result and temporal artery FDG uptake
Trial Locations
- Locations (1)
Department of Rheumatology
🇩🇰Aarhus, Denmark