Sponsor study identifier
observational
64
1 country
1
Study Start
May 15, 2016
Actual (reported)Primary Completion
January 28, 2020
Actual (reported)Study Completion
January 28, 2020
Actual (reported)Giant cell arteritis (GCA) is a medium to large vessel vasculitis with a predilection for the superficial cranial and intrathoracic arteries. Diagnosing the condition and predicting which patients will develop large vessel complications remains a challenge. There are limitations with temporal artery biopsy, magnetic resonance angiography and ultrasound of temporal arteries and American College of Rheumatology classification criteria. Positron emission tomography (PET) has been shown to be a useful modality in detecting inflammation in large intra-thoracic vessels but previously has not been able to accurately detect FDG uptake in the superficial cranial arteries due to poor spatial resolution. Newer scanners can perform finer cuts of the head and can detect uptake in these arteries. This study has three main components:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 28, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 9, 2016
Actual (reported)May 13, 2016
Actual (reported)May 15, 2016
Actual (reported)January 28, 2020
Actual (reported)January 28, 2020
Actual (reported)Diagnostic accuracy of FDG uptake in the superficial cranial or intrathoracic arteries for the diagnosis of temporal artery biopsy proven GCA amongst patients with suspected GCA
Baseline
Difference in aortic diameter at 24 months between patients with and without PET scan aortic uptake at time 0.
24 months
Difference in Th1 and Th17 axis cytokines in patients with and without thoracic large vessel PET uptake at 0, 6 and 24 months
24 months
Prevalence of varicella zoster virus antigen and DNA in temporal artery biopsy GCA specimens
24 months
Prevalence of acute varicella zoster IgM serology positivity in biopsy confirmed GCA patients
24 months
Difference in combined vascular events between GCA patients with and without thoracic large vessel PET uptake at 0, 6 and 24 months
24 months
Suspected GCA
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Sammel AM, Hsiao E, Schembri G, Nguyen K, Brewer J, Schrieber L, Janssen B, Youssef P, Fraser CL, Bailey E, Bailey DL, Roach P, Laurent R. Diagnostic Accuracy of Positron Emission Tomography/Computed Tomography of the Head, Neck, and Chest for Giant Cell Arteritis: A Prospective, Double-Blind, Cross-Sectional Study. Arthritis Rheumatol. 2019 Aug;71(8):1319-1328. doi: 10.1002/art.40864. Epub 2019 Jun 12.
Temporal artery specimens Serology
Anthony M Sammel, MBBS
Royal North Shore Hospital, St Leonards, Australia
64 participants (actual enrollment reported by the registry).
First Submitted
May 9, 2016
First Posted
May 13, 2016
Study Start
May 15, 2016
Actual (reported)Giant Cell Arteritis: Improving Use of Ultrasound Evaluation
Contact the study team to confirm eligibility.
Primary Completion
January 28, 2020
Actual (reported)Study Completion
January 28, 2020
Actual (reported)Last Updated
March 12, 2020
Record last verified: 2020-03
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Source: ClinicalTrials.gov.
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