Clinical Trials Directory

Trials / Completed

CompletedNCT02771483

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
Phase
Study type
Observational
Enrollment
64 (actual)
Sponsor
Royal North Shore Hospital · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

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

Conditions

Timeline

Start date
2016-05-15
Primary completion
2020-01-28
Completion
2020-01-28
First posted
2016-05-13
Last updated
2020-03-12

Locations

1 site across 1 country: Australia

Source: ClinicalTrials.gov record NCT02771483. Inclusion in this directory is not an endorsement.