Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Temporal Artery Biopsy vs ULtrasound in Diagnosis of GCA (TABUL) (TABUL)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00974883
Recruitment Status : Completed
First Posted : September 10, 2009
Last Update Posted : July 17, 2015
Sponsor:
Collaborators:
University of Sheffield
Southend University Hospital
Nuffield Orthopaedic Centre NHS Trust
Oxford University Hospitals NHS Trust
The Leeds Teaching Hospitals NHS Trust
University of Bristol
London School of Hygiene and Tropical Medicine
Medical Center for Rheumatology Berlin-Buch
Information provided by (Responsible Party):
University of Oxford

Brief Summary:

Giant Cell Arteritis (GCA) causes inflammation and narrowing of blood vessels and can cause blindness in one third of patients. It is important that a prompt, accurate diagnosis of GCA is made and treatment given as steroids for two or more years. Currently there is no 100% accurate test for GCA. Patients usually have new headache and scalp tenderness, typically with an abnormal blood test. However, it can be difficult to distinguish non-serious forms of headache from GCA; infection produces similar abnormal blood results. If there is a suspicion of GCA, treatment with steroids is started straight away. To confirm a diagnosis, the patient will need a biopsy of a temporal artery (a minor procedure performed under local anaesthetic to remove a sample of one of the scalp arteries). However, up to 44% of patients will have a normal biopsy. Therefore it is difficult to know if a patient with a normal biopsy does or does not have GCA. Withdrawing steroid treatment may increase the risk of blindness. Continuing treatment in a patient without GCA increases the risk of side effects (e.g., weight gain, infection risk, osteoporosis and fracture risk, high blood pressure, diabetes, cataracts). It is important to improve diagnostic tests for GCA. Another test to help in diagnosing GCA is an ultrasound scan of the arteries in the side of the head and under the arms. Ultrasound does not involve surgery; it is a simple test which can be performed as an out patient. Gel is applied to both sides of the head and under each arm. A sound probe is placed over the artery at each site to produce the scan.

The investigators' study will examine the role of ultrasound in diagnosis of 402 patients with suspected GCA. All patients will have an ultrasound examination in addition to biopsy within a week of starting steroids. Patients will be treated according to usual practice. After six months, the investigators will reassess the diagnosis. The investigators will look at the accuracy of ultrasound compared with or combined with biopsy. The investigators will look at how a doctor's knowledge of ultrasound results or biopsy results alone would affect the diagnosis and recommendation to continue or stop steroid treatment. The investigators will assess whether knowledge of both results together would alter the diagnosis and treatment. The investigators will collect information to estimate the costs of different ways of diagnosing GCA in relation to the impact on quality of life.


Condition or disease Intervention/treatment
Giant Cell Arteritis Procedure: Ultrasound of temporal and axillary arteries Procedure: Temporal artery biopsy

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 880 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Ultrasound Compared to Biopsy of Temporal Arteries in the Diagnosis and Treatment of Giant Cell Arteritis (GCA).
Study Start Date : June 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2014


Group/Cohort Intervention/treatment
Suspected GCA
Patients who present with new onset of headache and suspected diagnosis of GCA. They will all require a temporal artery biopsy to assist in the diagnosis
Procedure: Ultrasound of temporal and axillary arteries
Standardised assessment of temporal arteries and axillary arteries using high resolution ultrasound to detect halo, stenosis or occlusion
Other Name: Ultrasound scan

Procedure: Temporal artery biopsy
Biopsy of temporal artery from symptomatic side
Other Name: Biopsy of temporal artery

Training cohort
Patients with any condition or healthy volunteers who are willing to consent ot have their temporal and axillary arteries examined using ultrasound, for training purposes
Procedure: Ultrasound of temporal and axillary arteries
Standardised assessment of temporal arteries and axillary arteries using high resolution ultrasound to detect halo, stenosis or occlusion
Other Name: Ultrasound scan




Primary Outcome Measures :
  1. To evaluate the diagnostic accuracy of ultrasound vs temporal artery biopsy for diagnosis of suspected GCA and to evaluate the cost-effectiveness (incremental cost per QALY) of ultrasound instead of biopsy in the diagnosis of GCA. [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. To evaluate inter-observer agreement in the assessment of ultrasound and temporal artery biopsy [ Time Frame: Six months ]
  2. To elicit expert views on the appropriateness of performing a biopsy following ultrasound using clinical vignettes [ Time Frame: 3 years ]
  3. To evaluate the diagnostic accuracy (sensitivity and specificity) of the sequential diagnostic strategy as an alternative to temporal artery biopsy alone in the diagnosis of GCA [ Time Frame: 3 years ]
  4. To evaluate the cost-effectiveness (incremental cost per QALY) of the diagnostic strategy of combined ultrasound and biopsy instead of biopsy alone in the diagnosis of GCA. [ Time Frame: 3 years ]
  5. Specific adverse events measured at each assessment; daily and cumulative steroid dose; steroid side effects; and pain or dysaesthesia at the biopsy site. [ Time Frame: Six months ]
  6. Evolution of an alternative diagnosis [ Time Frame: Six months ]
  7. Negative predictive value of ultrasound in preventing the need for temporal artery biopsies. [ Time Frame: Six months ]
  8. Cost analysis of performing a screening ultrasound examination plus biopsy as part of the diagnostic workup of all patients with suspected GCA; or of performing a screening ultrasound examination instead of biopsy; or of performing a screening ultrasound [ Time Frame: Six months ]
  9. Cost analysis of performing a screening ultrasound examination instead of biopsy in cases with a very low probability of GCA as part of the diagnostic workup of all patients with suspected GCA. [ Time Frame: 3 years ]
  10. Prediction of potential harm done to patients by over diagnosis or under diagnosis of GCA as a result of ultrasound use, either alone or in combination with biopsy [ Time Frame: 3 years ]
  11. Value of axillary artery ultrasound scanning in contributing to the diagnosis of GCA. [ Time Frame: Six months ]
  12. Analysis of proportion of patients with a biopsy positive halo, stenosis, or occlusion assessed by high resolution ultrasound [ Time Frame: 3 years ]
  13. Presence of characteristic features of GCA on temporal artery biopsy in relation to clinical and ultrasound findings [ Time Frame: 2 weeks ]

Biospecimen Retention:   Samples With DNA
Temporal artery biopsy samples Serum Plasma White cells Video images of temporal and axillary arteries


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study cohort: Patients with suspected new giant cell arteritis Training cohort; patients or healthy volunteers willing to have temporal artery and axillary artery ultrasound examination
Criteria

Inclusion Criteria: for the cohort study

  1. A clinical suspicion of new diagnosis of GCA e.g. patients with a new onset of headache, scalp tenderness, with or without elevated CRP or ESR, jaw or tongue claudication with or without visual loss.
  2. The clinician decides that the patient requires an urgent temporal artery biopsy to determine whether or not the diagnosis is GCA.
  3. The patient agrees and provides NHS consent to undergo a temporal artery biopsy as part of standard care.
  4. Patients have been started on high dose glucocorticoids or will be started on high dose glucocorticoids.
  5. Patients must be willing to attend for an ultrasound scan of their temporal and axillary arteries.
  6. Participants must be willing to give informed written consent or willing to give permission for a nominated friend or relative to provide written informed assent if they are unable to do so because of physical disabilities e.g. sudden onset of blindness/vision loss which can be caused by GCA (this will be made clear in the ethics approval application).
  7. Must be 18 years of age or over.

For the training cases

  1. Patients attending hospital outpatient or in patient departments for assessment for any condition (apart from giant cell arteritis or polymyalgia rheumatica) or healthy staff volunteers.
  2. Above the age of 50 years.
  3. Willing to attend for an ultrasound scan of their temporal and axillary arteries.
  4. Willing and able to give written informed consent.

Exclusion criteria: for the cohort study

  1. Previous diagnosis of GCA.
  2. Use of high dose glucocorticoid (>20mg prednisolone/day) for management of current suspected GCA for more than 7 days prior to the dates of the ultrasound and biopsy.
  3. Long term (>1 month) high dose (>20mg per day at any time) steroids for conditions other than PMR, within three months prior to study entry.
  4. Inability to give informed consent (either written consent or verbal assent from a relative or carer)
  5. Inability to undergo an ultrasound scans of the temporal and axillary arteries.
  6. Patients with a known cause of headache (not due to GCA), or any condition which would preclude the need for a temporal artery biopsy.
  7. Patients who are unable to undergo an ultrasound scan and a temporal artery biopsy within 7 days of starting glucocorticoids.

For the training cases

  1. Diagnosis of suspected GCA or a previous history of diagnosed or suspected GCA.
  2. Inability to give written informed consent.
  3. Inability to undergo an ultrasound scans of the temporal and axillary arteries

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): NCT00974883


Locations
Show Show 27 study locations
Sponsors and Collaborators
University of Oxford
University of Sheffield
Southend University Hospital
Nuffield Orthopaedic Centre NHS Trust
Oxford University Hospitals NHS Trust
The Leeds Teaching Hospitals NHS Trust
University of Bristol
London School of Hygiene and Tropical Medicine
Medical Center for Rheumatology Berlin-Buch
Investigators
Layout table for investigator information
Study Chair: Raashid A Luqmani, DM FRCP University of Oxford
Principal Investigator: Andrew Hutchings London School of Hygiene and Tropical Medicine
Principal Investigator: Mike Bradburn University of Sheffield
Principal Investigator: Bhaskar Dasgupta University Hospital Southend
Principal Investigator: Allan Wailoo University of Sheffield
Principal Investigator: John Salmon John Radcliffe Hospital Oxford
Principal Investigator: Eugene McNally Nuffield Orthopaedic Centre Oxford
Principal Investigator: William Hamilton University of Bristol
Principal Investigator: Colin Pease Leeds General Infirmary
Principal Investigator: Brendan McDonald John Radcliffe Hospital Oxford
Principal Investigator: Konrad Wolfe University Hospital Southend
Principal Investigator: Wolfgang Schmidt Medical Centre for Rheumatology Berlin-Buch

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT00974883    
Other Study ID Numbers: 08/64/01
ISRCTN46280267 ( Other Identifier: http://www.controlled-trials.com/ISRCTN46280267/ )
First Posted: September 10, 2009    Key Record Dates
Last Update Posted: July 17, 2015
Last Verified: July 2015
Keywords provided by University of Oxford:
ultrasound
GCA
temporal arteritis
biopsy
Additional relevant MeSH terms:
Layout table for MeSH terms
Polymyalgia Rheumatica
Giant Cell Arteritis
Arteritis
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