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

August 12, 2015 updated by: University of Oxford

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with suspected or diagnosed giant cell arteritis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

University of Lisbon

Investigators

  • Principal Investigator: Raashid A Luqmani, DM FRCP, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

August 4, 2015

First Submitted That Met QC Criteria

August 12, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Estimate)

August 14, 2015

Last Update Submitted That Met QC Criteria

August 12, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9776

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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