Giant Cell ArteritisGAULTNCT02523625
Giant Cell Arteritis: Improving Use of Ultrasound Evaluation
An observational study of Giant Cell Arteritis, run by University of Oxford.
Trial summary
Giant cell arteritis (GCA) is an inflammatory disease causing new, unaccustomed headache in the elderly and which can lead to blindness in 20-30% of untreated cases. The study group have previously shown that ultrasound is a viable non-invasive alternative to temporal artery biopsy in diagnosing GCA. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Giant Cell Arteritis
- What is being tested?
- Ultrasound of temporal and axillary arteries
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Jun 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with suspected or diagnosed giant cell arteritis
Who may be able to join
- Healthy volunteer or
- Patient with a suspected diagnosis of GCA but found not to have GCA
- Recent diagnosis of GCA within 1 month or
- Suspected flare of GCA within one month
- Ability to provide written informed consent
Who cannot join
- Unable to provide written informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Can we Use Ultrasound in the Diagnosis and Monitoring of Patients With Giant Cell Arteritis?
Giant cell arteritis (GCA) is an inflammatory disease causing new, unaccustomed headache in the elderly and which can lead to blindness in 20-30% of untreated cases. The study group have previously shown that ultrasound is a viable non-invasive alternative to temporal artery biopsy in diagnosing GCA. However, there is significant variation in ultrasound assessment (measuring a dark "halo" around the abnormal blood vessels) between sonographers in different centres, requiring a labour intensive and time consuming training programme. The study group propose to standardise the training programme, and use ultrasound and clinical evaluation to define changes occurring over time and with treatment in patients with a diagnosis of GCA made based on ultrasound changes alone. The study group will explore the use of algorithms to automate or semi-automate image interpretation.
Read the detailed description
Objectives and Project Plan:
- Project Purpose:
The purpose of the project is to develop the technology to reliably acquire and analyse ultrasound images through the use of a training programme which are comparable to those from scanning by an expert sonographer in the diagnosis (i.e. as a diagnostic tool) and monitoring of patients with GCA following treatment (i.e. as a response indicator), and patient stratification according to initial or early scan changes to determine the most appropriate treatment (i.e. as a prognostic tool).
- End Point:
The end point will be the production of an effective training programme which can be used to obtain reproducible accurate ultrasound images of the temporal artery which can be automatically analysed and used in real time in the management of patients with suspected or confirmed giant cell arteritis.
- Milestones:
The project is in 3 phases. In phase 1 (0-12 months) the study group will create a bank of images for training from healthy volunteers and patients with GCA; in phase 2 (13-18 months) the study group will test the programme on sonographers assessing patients with GCA; in phase 3 (19-42 months) the study group will acquire serial images, clinical data, serum and plasma from cohorts of patients with newly diagnosed and flaring GCA so that they can analyse and develop new software algorithms. The study group can use images already acquired from a previous diagnostic study in GCA, and test the algorithms on the new cohorts..
- Conditions
- Giant Cell Arteritis
- Being tested
- Ultrasound of temporal and axillary arteries
- Keywords
- Ultrasound
- 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.
Ultrasound of temporal and axillary arteriesDevice
Each patient will have a clinical assessment and ultrasound examination of both temporal and axillary arteries
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Age and gender matched to patient groups to undergo ultrasound of temporal and axillary arteries Receives: Device: Ultrasound of temporal and axillary arteries | |
| Patients with headache | Patients with new headache not due to GCA to undergo ultrasound of temporal and axillary arteries Receives: Device: Ultrasound of temporal and axillary arteries | |
| Patients with GCA (new) | Patients with new diagnosis of GCA to undergo ultrasound of temporal and axillary arteries Receives: Device: Ultrasound of temporal and axillary arteries | |
| Patients with GCA (flare) | Patients with apparent flare of GCA to undergo ultrasound of temporal and axillary arteries Receives: Device: Ultrasound of temporal and axillary arteries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of halo detected (mm) on ultrasound of temporal arteries
The study group will compare computer algorithms to analyse the halo size from video images of ultrasound scans with observer defined measures of halo size (mm) from healthy volunteers, patients with headache but not due to GCA, patients with newly diagnosed GCA and in patients with GCA who are followed serially and re-imaged over time in response to therapy. The study group will test the value of algorithms incorporating clinical and serological data together with the imaging findings to determine their added effect on the sensitivity and specificity of ultrasound for diagnosis and monitoring of GCA. Halo size varies from 0 (undetectable) to greater than 1mm. Cut-off values for abnormal values have not been formally established or published yet.
Measured: 24 months
Secondary outcomes (2)
Circulating serum Vascular Endothelial Growth Factor (VEGF) levels
The study group will measure VEGF levels in serum taken from age matched controls presenting with headache, patients with newly diagnosed GCA and patients with established GCA undergoing a flare, to determine the value of VEGF in predicting diagnosis, response to therapy, flare or prognosis in GCA.
Measured: 24 months
Circulating serum Pentraxin 3 levels
The study group will measure pentraxin 3 levels in serum taken from age matched controls presenting with headache, patients with newly diagnosed GCA and patients with established GCA undergoing a flare, to determine the value of pentraxin 3 in predicting diagnosis, response to therapy, flare or prognosis in GCA.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lisbon
- Responsible party
- Sponsor
- Investigators
- Raashid A Luqmani, DM FRCP, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523625
- Sponsor's protocol ID
- 9776
- Acronym
- GAULT
- Status last verified
- Aug 2015
- First submitted
- 4 Aug 2015
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ponte C, Rodrigues AF, O'Neill L, Luqmani RA. Giant cell arteritis: Current treatment and management. World J Clin Cases. 2015 Jun 16;3(6):484-94. doi: 10.12998/wjcc.v3.i6.484.
PubMed 26090367Diamantopoulos AP, Myklebust G. Long-term inflammation in the temporal artery of a giant cell arteritis patient as detected by ultrasound. Ther Adv Musculoskelet Dis. 2014 Jun;6(3):102-3. doi: 10.1177/1759720X14521109. No abstract available.
PubMed 24891881Schmidt WA. Ultrasound in vasculitis. Clin Exp Rheumatol. 2014 Jan-Feb;32(1 Suppl 80):S71-7. Epub 2014 Feb 17.
PubMed 24529335Diamantopoulos AP, Haugeberg G, Hetland H, Soldal DM, Bie R, Myklebust G. Diagnostic value of color Doppler ultrasonography of temporal arteries and large vessels in giant cell arteritis: a consecutive case series. Arthritis Care Res (Hoboken). 2014 Jan;66(1):113-9. doi: 10.1002/acr.22178.
PubMed 24106211Muratore F, Boiardi L, Restuccia G, Macchioni P, Pazzola G, Nicolini A, Germano G, Possemato N, Cavazza A, Cavuto S, Cimino L, Pipitone N, Catanoso M, Addimanda O, Salvarani C. Comparison between colour duplex sonography findings and different histological patterns of temporal artery. Rheumatology (Oxford). 2013 Dec;52(12):2268-74. doi: 10.1093/rheumatology/ket258. Epub 2013 Sep 17.
PubMed 24046471Habib HM, Essa AA, Hassan AA. Color duplex ultrasonography of temporal arteries: role in diagnosis and follow-up of suspected cases of temporal arteritis. Clin Rheumatol. 2012 Feb;31(2):231-7. doi: 10.1007/s10067-011-1808-0. Epub 2011 Jul 9.
PubMed 21743987
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can we Use Ultrasound in the Diagnosis and Monitoring of Patients With Giant Cell Arteritis?
- ClinicalTrials.gov ID
- NCT02523625
- Acronym / sponsor ID
- GAULT / 9776
- Conditions
- Giant Cell Arteritis
- Keywords
- Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- University of Lisbon
- Study start
- Oct 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 14 Aug 2015 (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 an inflammatory disease causing new, unaccustomed headache in the elderly and which can lead to blindness in 20-30% of untreated cases. The study group have previously shown that ultrasound is a viable non-invasive alternative to temporal artery biopsy in diagnosing GCA. However, there is significant variation in ultrasound assessment (measuring a dark "halo" around the abnormal blood vessels) between sonographers in different centres, requiring a labour intensive and time consuming training programme. The study group propose to standardise the training programme, and use ultrasound and clinical evaluation to define changes occurring over time and with treatment in patients with a diagnosis of GCA made based on ultrasound changes alone. The study group will explore the use of algorithms to automate or semi-automate image interpretation.
Detailed description
Objectives and Project Plan:
- Project Purpose:
The purpose of the project is to develop the technology to reliably acquire and analyse ultrasound images through the use of a training programme which are comparable to those from scanning by an expert sonographer in the diagnosis (i.e. as a diagnostic tool) and monitoring of patients with GCA following treatment (i.e. as a response indicator), and patient stratification according to initial or early scan changes to determine the most appropriate treatment (i.e. as a prognostic tool).
- End Point:
The end point will be the production of an effective training programme which can be used to obtain reproducible accurate ultrasound images of the temporal artery which can be automatically analysed and used in real time in the management of patients with suspected or confirmed giant cell arteritis.
- Milestones:
The project is in 3 phases. In phase 1 (0-12 months) the study group will create a bank of images for training from healthy volunteers and patients with GCA; in phase 2 (13-18 months) the study group will test the programme on sonographers assessing patients with GCA; in phase 3 (19-42 months) the study group will acquire serial images, clinical data, serum and plasma from cohorts of patients with newly diagnosed and flaring GCA so that they can analyse and develop new software algorithms. The study group can use images already acquired from a previous diagnostic study in GCA, and test the algorithms on the new cohorts..
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Device: Ultrasound of temporal and axillary arteriesAge and gender matched to patient groups to undergo ultrasound of temporal and axillary arteries |
| Patients with headache | – | Device: Ultrasound of temporal and axillary arteriesPatients with new headache not due to GCA to undergo ultrasound of temporal and axillary arteries |
| Patients with GCA (new) | – | Device: Ultrasound of temporal and axillary arteriesPatients with new diagnosis of GCA to undergo ultrasound of temporal and axillary arteries |
| Patients with GCA (flare) | – | Device: Ultrasound of temporal and axillary arteriesPatients with apparent flare of GCA to undergo ultrasound of temporal and axillary arteries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected or diagnosed giant cell arteritis
Key inclusion criteria (5 listed)
- Healthy volunteer or
- Patient with a suspected diagnosis of GCA but found not to have GCA
- Recent diagnosis of GCA within 1 month or
- Suspected flare of GCA within one month
- Ability to provide written informed consent
Key exclusion criteria (1 listed)
- Unable to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound of temporal and axillary arteriesEach patient will have a clinical assessment and ultrasound examination of both temporal and axillary arteries | Device | Healthy volunteers, Patients with GCA (flare), Patients with GCA (new), Patients with headache |
Primary outcome
Size of halo detected (mm) on ultrasound of temporal arteries
Time frame: 24 months
The study group will compare computer algorithms to analyse the halo size from video images of ultrasound scans with observer defined measures of halo size (mm) from healthy volunteers, patients with headache but not due to GCA, patients with newly diagnosed GCA and in patients with GCA who are followed serially and re-imaged over time in response to therapy. The study group will test the value of algorithms incorporating clinical and serological data together with the imaging findings to determine their added effect on the sensitivity and specificity of ultrasound for diagnosis and monitoring of GCA. Halo size varies from 0 (undetectable) to greater than 1mm. Cut-off values for abnormal values have not been formally established or published yet.
2 secondary outcomes
Circulating serum Vascular Endothelial Growth Factor (VEGF) levels
Time frame: 24 months
Circulating serum Pentraxin 3 levels
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
- Results publication: PubMed 26090367Ponte C, Rodrigues AF, O'Neill L, Luqmani RA. Giant cell arteritis: Current treatment and management. World J Clin Cases. 2015 Jun 16;3(6):484-94. doi: 10.12998/wjcc.v3.i6.484.
- Results publication: PubMed 24891881Diamantopoulos AP, Myklebust G. Long-term inflammation in the temporal artery of a giant cell arteritis patient as detected by ultrasound. Ther Adv Musculoskelet Dis. 2014 Jun;6(3):102-3. doi: 10.1177/1759720X14521109. No abstract available.
- Results publication: PubMed 24529335Schmidt WA. Ultrasound in vasculitis. Clin Exp Rheumatol. 2014 Jan-Feb;32(1 Suppl 80):S71-7. Epub 2014 Feb 17.
- Results publication: PubMed 24106211Diamantopoulos AP, Haugeberg G, Hetland H, Soldal DM, Bie R, Myklebust G. Diagnostic value of color Doppler ultrasonography of temporal arteries and large vessels in giant cell arteritis: a consecutive case series. Arthritis Care Res (Hoboken). 2014 Jan;66(1):113-9. doi: 10.1002/acr.22178.
- Results publication: PubMed 24046471Muratore F, Boiardi L, Restuccia G, Macchioni P, Pazzola G, Nicolini A, Germano G, Possemato N, Cavazza A, Cavuto S, Cimino L, Pipitone N, Catanoso M, Addimanda O, Salvarani C. Comparison between colour duplex sonography findings and different histological patterns of temporal artery. Rheumatology (Oxford). 2013 Dec;52(12):2268-74. doi: 10.1093/rheumatology/ket258. Epub 2013 Sep 17.
- Results publication: PubMed 21743987Habib HM, Essa AA, Hassan AA. Color duplex ultrasonography of temporal arteries: role in diagnosis and follow-up of suspected cases of temporal arteritis. Clin Rheumatol. 2012 Feb;31(2):231-7. doi: 10.1007/s10067-011-1808-0. Epub 2011 Jul 9.
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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.
Raashid A Luqmani, DM FRCP principal investigator
University of Oxford
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis, run by University of Oxford.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raashid A Luqmani, DM FRCP (01865227971, raashid.luqmani@ndorms.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of halo detected (mm) on ultrasound of temporal arteries (time frame: 24 months). 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 NCT02523625, which also lists 6 linked publications.
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 14 Aug 2015.