Giant Cell Arteritis and PET Scan (GAPS) Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02771483

Enrollment

Registered

2016-05-13

Start date

2016-05-15

Completion date

2020-01-28

Last updated

2020-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant Cell Arteritis

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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 1. Age \>= 50 2. ESR \>= 50 3. New onset localised headache 4. Temporal artery abnormality (tenderness or decreased pulsation) 5. 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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
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 aortic diameter at 24 months between patients with and without PET scan aortic uptake at time 0.	24 months
Difference in temporal artery histology between GCA patients with and without thoracic large vessel PET uptake at 0 months	Baseline
Difference in temporal artery histology between GCA patients with and without temporal artery PET uptake at 0 months	Baseline
Difference in combined vascular events between GCA patients with and without thoracic large vessel PET uptake at 0, 6 and 24 months	24 months

Countries

Australia

Outcome results