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Diagnostic Accuracy of FDG PET/CT of Cranial Arteries in GCA

Conventional FDG PET/CT Accurately Diagnoses Temporal Arteritis in Glucocorticoid-naïve GCA Patients: a Case-control Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03409913
Enrollment
106
Registered
2018-01-24
Start date
2014-10-01
Completion date
2017-12-31
Last updated
2018-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant Cell Arteritis

Keywords

positron emissions tomography, diagnostic accuracy, case-control

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.

Interventions

RADIATIONFDG PET/CT

Conventional FDG PET/CT including head in order to asses cranial arteries.

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Cases: * 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 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

Exclusion criteria

* Previous diagnosis of polymyalgia or giant cell arteritis * immunosuppresive treatment within last month

Design outcomes

Primary

MeasureTime frameDescription
PET positivityTime 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

MeasureTime frameDescription
Full-fillment of ACR criteriaTime of diagnosisPET sensitivity and specificity in the subpopulation of GCA patients full filling ACR criteria
Temporal artery biopsyTime of diagnosisCorrelation between temporal artery biopsy result and temporal artery FDG uptake
Temporal artery ultrasoundTime of diagnosisCorrelation between temporal artery ultrasound result and temporal artery FDG uptake

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026