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NCT Number: NCT02771483

Giant Cell Arteritis and PET Scan (GAPS) Study

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:

1. Cross sectional study assessing the accuracy of PET uptake in the superficial cranial and intrathoracic arteries of suspected GCA patients for the diagnosis of GCA 2. Cohort study assessing the prognostic implication of FDG aortic uptake on aortic diameter at 24 months 3. Cohort study assessing the Th1 and Th17 cytokine profile in patients with and without FDG PET uptake at 0, 6 and 24 months

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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

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Rheumatologist, neurologist or ophthalmologist suspect diagnosis of GCA
  • Age > 50
  • Meet at least 2 of 1990 American College of Rheumatology classification criteria for GCA
  • Age >= 50
  • ESR >= 50
  • New onset localised headache
  • Temporal artery abnormality (tenderness or decreased pulsation)
  • Positive biopsy (will not be available at time of enrolment)

Exclusion criteria

  • Corticosteroid therapy for > 72 hours before first PET scan
  • Prolonged corticosteroid therapy (> 1 week) for another indication in past 6 months
  • History of vasculitis or connective tissue disease
  • Active malignancy

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: Baseline

Secondary outcomes

  1. Difference in aortic diameter at 24 months between patients with and without PET scan aortic uptake at time 0.

    Time frame: 24 months

  2. Difference in Th1 and Th17 axis cytokines in patients with and without thoracic large vessel PET uptake at 0, 6 and 24 months

    Time frame: 24 months

  3. Prevalence of varicella zoster virus antigen and DNA in temporal artery biopsy GCA specimens

    Time frame: 24 months

  4. Prevalence of acute varicella zoster IgM serology positivity in biopsy confirmed GCA patients

    Time frame: 24 months

  5. Difference in combined vascular events between GCA patients with and without thoracic large vessel PET uptake at 0, 6 and 24 months

    Time frame: 24 months

  6. Difference in temporal artery histology between GCA patients with and without thoracic large vessel PET uptake at 0 months

    Time frame: Baseline

  7. Difference in temporal artery histology between GCA patients with and without temporal artery PET uptake at 0 months

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Royal North Shore Hospital

Other

Registry information

Official study title

Giant Cell Arteritis and PET Scan (GAPS) Study - Improving the Diagnosis and Prognostication of Giant Cell Arteritis Through the Novel Use of Positron Emission Tomography and Immune Biomarkers

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 13, 2016
Registry last updated
Mar 12, 2020

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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