- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05246540
Evaluation of PET/CT of Cephalic Arteries for the Diagnosis of Giant Cell Arteritis (Cervico-TEP et)
Giant cell arteritis (GCA) is the most common vasculitis in adults. The diagnosis of GCA is evoked by the association of clinical signs and biological anomalies (inflammatory syndrome) in patients over 50 years of age. On the other hand, starting a treatment implies being certain of the diagnosis which requires performing a temporal artery biopsy under local anesthesia. This examination is therefore an invasive procedure for patients whose sensitivity is not optimal. This is why imaging techniques (echo-Doppler or MRI of the temporal arteries) have been developed to look for signs of vasculitis without the need to perform a biopsy. However, these examinations lack sensitivity (=falsely concluding the absence of GCA) and specificity (=falsely concluding the presence of GCA). Recently, advances in imaging, and in particular positron emission tomography (PET), have made it possible to visualize the cephalic arteries, including the temporal artery.
The aim of this study is therefore to evaluate the sensitivity and specificity of PET of the cephalic arteries for the diagnosis of GCA and to compare them with those of echo-Doppler and MRI of the temporal arteries.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Dijon, France, 21000
- CHU Dijon Bourgogne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Any patient for which the diagnosis of GCA is suspected and who underwent a cervical PET/CT
Exclusion Criteria:
- previously diagnosed GCA, glycemia > 7 mmol/L, PET CT performed more than 72 h after introduction of glucocorticoids, age < 50 years
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patients
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Data collection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sensitivity / specificity of cervical PET/CT for the diagnosis of GCA
Time Frame: 6 months
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diagnosis retained by the clinician without question after 6 months of follow-up and treatment for at least 6 consecutive months
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6 months
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Autoimmune Diseases
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Skin Diseases
- Skin Diseases, Vascular
- Vasculitis
- Vasculitis, Central Nervous System
- Arteritis
- Skin and Connective Tissue Diseases
- Giant Cell Arteritis
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Data Collection
Other Study ID Numbers
- ALBERINI CHU 2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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