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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02771483




Registration number
NCT02771483
Ethics application status
Date submitted
9/05/2016
Date registered
13/05/2016
Date last updated
12/03/2020

Titles & IDs
Public title
Giant Cell Arteritis and PET Scan (GAPS) Study
Scientific 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
Secondary ID [1] 0 0
RESP/16/44
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Giant Cell Arteritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Suspected GCA (GCA final diagnosis) -

Suspected GCA (alternative final diagnosis) -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline
Secondary outcome [1] 0 0
Difference in aortic diameter at 24 months between patients with and without PET scan aortic uptake at time 0.
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Difference in Th1 and Th17 axis cytokines in patients with and without thoracic large vessel PET uptake at 0, 6 and 24 months
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Prevalence of varicella zoster virus antigen and DNA in temporal artery biopsy GCA specimens
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Prevalence of acute varicella zoster IgM serology positivity in biopsy confirmed GCA patients
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Difference in combined vascular events between GCA patients with and without thoracic large vessel PET uptake at 0, 6 and 24 months
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Difference in temporal artery histology between GCA patients with and without thoracic large vessel PET uptake at 0 months
Timepoint [6] 0 0
Baseline
Secondary outcome [7] 0 0
Difference in temporal artery histology between GCA patients with and without temporal artery PET uptake at 0 months
Timepoint [7] 0 0
Baseline

Eligibility
Key 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)
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/01/2020
Sample size
Target
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT02771483
Trial related presentations / publications
Sammel AM, Hsiao E, Schembri G, Nguyen K, Brewer J, Schrieber L, Janssen B, Youssef P, Fraser CL, Bailey E, Bailey DL, Roach P, Laurent R. Diagnostic Accuracy of Positron Emission Tomography/Computed Tomography of the Head, Neck, and Chest for Giant Cell Arteritis: A Prospective, Double-Blind, Cross-Sectional Study. Arthritis Rheumatol. 2019 Aug;71(8):1319-1328. doi: 10.1002/art.40864. Epub 2019 Jun 12.
Public notes

Contacts
Principal investigator
Name 0 0
Anthony M Sammel, MBBS
Address 0 0
Royal North Shore Hospital, St Leonards, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02771483