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NCT Number: NCT03409913

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

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.

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Key information

Conditions

Giant Cell Arteritis Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Immune System Diseases Nervous System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Rheumatology

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FDG PET/CT

Radiation

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

Other names: Temporal artery biopsy, Vascular ultrasound, Inflammatory biomarkers

Primary outcomes

  1. PET positivity

    Time frame: 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 outcomes

  1. Full-fillment of ACR criteria

    Time frame: Time of diagnosis

    PET sensitivity and specificity in the subpopulation of GCA patients full filling ACR criteria

  2. Temporal artery biopsy

    Time frame: Time of diagnosis

    Correlation between temporal artery biopsy result and temporal artery FDG uptake

  3. Temporal artery ultrasound

    Time frame: Time of diagnosis

    Correlation between temporal artery ultrasound result and temporal artery FDG uptake

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 24, 2018
Registry last updated
Jan 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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