Giant Cell Arteritis and PET Scan (GAPS) Study

Giant Cell Arteritis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02771483
• Other study ID #: RESP/16/44
• Status: Completed
• Start date: May 15, 2016
• Est. completion date: January 28, 2020

Study information

• Verified date: March 2020
• Source: Royal North Shore Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 28, 2020
• Est. primary completion date: January 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

Locations

Country	Name	City	State
Australia	Royal North Shore Hospital	St Leonards	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Royal North Shore Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in aortic diameter at 24 months between patients with and without PET scan aortic uptake at time 0.		24 months
Secondary	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
Secondary	Prevalence of varicella zoster virus antigen and DNA in temporal artery biopsy GCA specimens		24 months
Secondary	Prevalence of acute varicella zoster IgM serology positivity in biopsy confirmed GCA patients		24 months
Secondary	Difference in combined vascular events between GCA patients with and without thoracic large vessel PET uptake at 0, 6 and 24 months		24 months
Secondary	Difference in temporal artery histology between GCA patients with and without thoracic large vessel PET uptake at 0 months		Baseline
Secondary	Difference in temporal artery histology between GCA patients with and without temporal artery PET uptake at 0 months		Baseline