Giant Cell ArteritisNCT02771483
Giant Cell Arteritis and PET Scan (GAPS) Study
An observational study of Giant Cell Arteritis, run by Royal North Shore Hospital at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis
- How many people
- 64 participants
- Where
- 1 siteAustralia
- Study dates
- 15 May 2016to 28 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Suspected GCA
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Royal North Shore Hospital
St Leonards, New South Wales, 2065
About this study
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
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.
Read more
This study has three main components:
- 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
- Cohort study assessing the prognostic implication of FDG aortic uptake on aortic diameter at 24 months
- Cohort study assessing the Th1 and Th17 cytokine profile in patients with and without FDG PET uptake at 0, 6 and 24 months
- Conditions
- Giant Cell Arteritis
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Suspected GCA (GCA final diagnosis) | Not described | |
| Suspected GCA (alternative final diagnosis) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (7)
Difference in aortic diameter at 24 months between patients with and without PET scan aortic uptake at time 0.
Measured: 24 months
Difference in Th1 and Th17 axis cytokines in patients with and without thoracic large vessel PET uptake at 0, 6 and 24 months
Measured: 24 months
Prevalence of varicella zoster virus antigen and DNA in temporal artery biopsy GCA specimens
Measured: 24 months
Prevalence of acute varicella zoster IgM serology positivity in biopsy confirmed GCA patients
Measured: 24 months
Difference in combined vascular events between GCA patients with and without thoracic large vessel PET uptake at 0, 6 and 24 months
Measured: 24 months
Difference in temporal artery histology between GCA patients with and without thoracic large vessel PET uptake at 0 months
Measured: Baseline
Difference in temporal artery histology between GCA patients with and without temporal artery PET uptake at 0 months
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study start15 May 2016
- Primary completion28 Jan 2020
- Study completion28 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal North Shore Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Sammel, Royal North Shore Hospital
- Investigators
- Anthony M Sammel, MBBS, Principal investigator, Royal North Shore Hospital, St Leonards, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771483
- Sponsor's protocol ID
- RESP/16/44
- Status last verified
- Mar 2020
- First submitted
- 9 May 2016
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 30848549
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02771483
- Acronym / sponsor ID
- RESP/16/44
- Conditions
- Giant Cell Arteritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Royal North Shore HospitalUniversity, hospital or other
- Study start
- 15 May 2016 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 28 Jan 2020 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Cohort study assessing the prognostic implication of FDG aortic uptake on aortic diameter at 24 months
- Cohort study assessing the Th1 and Th17 cytokine profile in patients with and without FDG PET uptake at 0, 6 and 24 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suspected GCA (GCA final diagnosis) | – | – |
| Suspected GCA (alternative final diagnosis) | – | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Suspected GCA
Key inclusion criteria (8 listed)
- Rheumatologist, neurologist or ophthalmologist suspect diagnosis of GCA
- Age > 50
- Meet at least 2 of 1990 American College of Rheumatology classification criteria for GCA
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
Difference in aortic diameter at 24 months between patients with and without PET scan aortic uptake at time 0.
Time frame: 24 months
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
Prevalence of varicella zoster virus antigen and DNA in temporal artery biopsy GCA specimens
Time frame: 24 months
Prevalence of acute varicella zoster IgM serology positivity in biopsy confirmed GCA patients
Time frame: 24 months
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
Difference in temporal artery histology between GCA patients with and without thoracic large vessel PET uptake at 0 months
Time frame: Baseline
Difference in temporal artery histology between GCA patients with and without temporal artery PET uptake at 0 months
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Derived from this study: PubMed 30848549Sammel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony M Sammel, MBBS principal investigator
Royal North Shore Hospital, St Leonards, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis, run by Royal North Shore Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02771483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.