Diagnostic Accuracy of FDG PET/CT of Cranial Arteries in GCA
NCT ID: NCT03409913
Last Updated: 2018-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
106 participants
OBSERVATIONAL
2014-10-01
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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GCA cases
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.
FDG PET/CT
Conventional FDG PET/CT including head in order to asses cranial arteries.
controls
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
FDG PET/CT
Conventional FDG PET/CT including head in order to asses cranial arteries.
Interventions
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FDG PET/CT
Conventional FDG PET/CT including head in order to asses cranial arteries.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* immunosuppresive treatment within last month
50 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Lars Christian Gormsen, MD, PhD
Role: STUDY_CHAIR
Department of Nuclear Medicine and PET centre, Aarhus University Hospital
Locations
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Department of Rheumatology
Aarhus, , Denmark
Countries
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Other Identifiers
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Cranial_GCA_PET
Identifier Type: -
Identifier Source: org_study_id
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