ROUGE V1

• Research type

  Research Study

• Full title

  ROUGE: : The Role of Tomographic Ultrasound in Giant Cell Arteritis

• IRAS ID

  158211

• Contact name

  Sahena Haque

• Sponsor organisation

  University Hospital of South Manchester

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  Giant cell arteritis (GCA) is due to inflammation of bloods vessels, typically occurring above the age of 60. It normally presents with a combination of new headache, scalp tenderness, jaw pain and visual disturbance. It is a potentially eyesight threatening condition requiring urgent treatment with high doses of steroids.

  Despite advances in medicine there is a lot we still do not understand about this condition. At present, a sample of the affected blood vessel, usually from the temporal area of the scalp is needed to help make the diagnosis. However, even if a tissue sample is obtained, this is still only positive in 20-40% of patients with the condition.

  There is increasing interest in the use of ultrasound to identify typical changes which occur in blood vessels. Work with standard ultrasound machines has been promising but only limited information has been obtained.

  High resolution tomographic ultrasound (tUS) is more sensitive and accurate when compared to standard ultrasound providing more detailed information. To date there has been no formal study looking at the role of tUS in GCA. This is potentially an accurate and non-invasive method of diagnosing GCA in the long term and the aim of this study is to look at the feasibility of tUS in this context.

  We propose to perform a tUS along side the routine blood tests and biopsy a patient would have as part of standard care. Patients will be recruited over a 1 year period from local centres who are taking part in the study. They will attend the UHSM for the tUS.

  Although blood tests are routinely taken, little is understood about the pathophysiology of the condition. As such an (optional) additional 10 ml blood sample will be taken to allow further analysis at a later date.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  16/NE/0055

• Date of REC Opinion

  12 Feb 2016

• REC opinion

  Favourable Opinion