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Giant Cell Arteritis: Improving Use of Ultrasound Evaluation (GAULT)

This study is not yet open for participant recruitment.
Verified August 2015 by University of Oxford
Sponsor:
ClinicalTrials.gov Identifier:
NCT02523625
First Posted: August 14, 2015
Last Update Posted: August 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Lisbon
Information provided by (Responsible Party):
University of Oxford
  Purpose
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.

Condition Intervention
Giant Cell Arteritis Device: Ultrasound of temporal and axillary arteries

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can we Use Ultrasound in the Diagnosis and Monitoring of Patients With Giant Cell Arteritis?

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Circulating serum Vascular Endothelial Growth Factor (VEGF) levels [ Time Frame: 24 months ]
    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.

  • Circulating serum Pentraxin 3 levels [ Time Frame: 24 months ]
    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.


Biospecimen Retention:   Samples With DNA
Serum Plasma Whole blood

Estimated Enrollment: 250
Study Start Date: October 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy volunteers
Age and gender matched to patient groups to undergo ultrasound of temporal and axillary arteries
Device: Ultrasound of temporal and axillary arteries
Each patient will have a clinical assessment and ultrasound examination of both temporal and axillary arteries
Patients with headache
Patients with new headache not due to GCA to undergo ultrasound of temporal and axillary arteries
Device: Ultrasound of temporal and axillary arteries
Each patient will have a clinical assessment and ultrasound examination of both temporal and axillary arteries
Patients with GCA (new)
Patients with new diagnosis of GCA to undergo ultrasound of temporal and axillary arteries
Device: Ultrasound of temporal and axillary arteries
Each patient will have a clinical assessment and ultrasound examination of both temporal and axillary arteries
Patients with GCA (flare)
Patients with apparent flare of GCA to undergo ultrasound of temporal and axillary arteries
Device: Ultrasound of temporal and axillary arteries
Each patient will have a clinical assessment and ultrasound examination of both temporal and axillary arteries

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..

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected or diagnosed giant cell arteritis
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Unable to provide written informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523625


Contacts
Contact: Raashid A Luqmani, DM FRCP 01865227971 raashid.luqmani@ndorms.ox.ac.uk
Contact: Jana Vaskova 01865227971 jana.vaskova@ndorms.ox.ac.uk

Sponsors and Collaborators
University of Oxford
University of Lisbon
Investigators
Principal Investigator: Raashid A Luqmani, DM FRCP University of Oxford
  More Information

Publications:
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02523625     History of Changes
Other Study ID Numbers: 9776
First Submitted: August 4, 2015
First Posted: August 14, 2015
Last Update Posted: August 14, 2015
Last Verified: August 2015

Keywords provided by University of Oxford:
Ultrasound

Additional relevant MeSH terms:
Arteritis
Giant Cell Arteritis
Polymyalgia Rheumatica
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases