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

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.

Conditions

• Giant Cell Arteritis

Interventions

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

PROCEDURE

Temporal artery biopsy

Biopsy of temporal artery from symptomatic side

Sponsors & Collaborators

• University of Sheffield

  collaborator OTHER

• Mid and South Essex NHS Foundation Trust

  collaborator OTHER

• Nuffield Orthopaedic Centre NHS Trust

  collaborator OTHER

• Oxford University Hospitals NHS Trust

  collaborator OTHER

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• University of Bristol

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Medical Center for Rheumatology Berlin-Buch

  collaborator UNKNOWN

• University of Oxford

  lead OTHER

Principal Investigators

• Raashid A Luqmani, DM FRCP · University of Oxford

• Andrew Hutchings · London School of Hygiene and Tropical Medicine

• Mike Bradburn · University of Sheffield

• Bhaskar Dasgupta · University Hospital Southend

• Allan Wailoo · University of Sheffield

• John Salmon · John Radcliffe Hospital, Oxford

• Eugene McNally · Nuffield Orthopaedic Centre Oxford

• William Hamilton · University of Bristol

• Colin Pease · Leeds General Infirmary

• Brendan McDonald · John Radcliffe Hospital, Oxford

• Konrad Wolfe · University Hospital Southend

• Wolfgang Schmidt · Medical Centre for Rheumatology Berlin-Buch

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2013-12-31

Completion

2014-12-31

Countries

• Germany
• Ireland
• Norway
• Portugal
• United Kingdom

Study Locations