Molecular Imaging Methods in Primary Sjögren’s Syndrome

• Research type

  Research Study

• Full title

  A Pilot Study to Evaluate Molecular Imaging Methods in Primary Sjögren’s Syndrome

• IRAS ID

  210289

• Contact name

  Michele Bombardieri

• Contact email

  m.bombardieri@qmul.ac.uk

• Sponsor organisation

  GlaxoSmithKline Research & Development Limited

• Duration of Study in the UK

  0 years, 11 months, 0 days

• Research summary

  This is a pilot (preliminary) study to assess the potential value of specific imaging methods in characterising and measuring the symptoms of disease in patients with Primary Sjögren’s Syndrome (pSS) and comparing it with Healthy Volunteer.

  Primary Sjogren's (SHOW-grins) syndrome is a chronic (long-lasting) disorder of the immune system that causes insufficient moisture production in some glands of the body, primarily in the eyes (lacrimal glands) and mouth (salivary glands) — resulting in dry eyes and mouth, as well as several other symptoms including joint pains and severe tiredness. Sometimes internal organs can be affected.

  Although you can develop Sjogren's syndrome at any age, most people are older than 40 at the time of diagnosis. The condition is much more common in women. Current treatment focuses on relieving symptoms and there is no known cure for this condition. Many patients are currently diagnosed with the disease several years after the onset of symptoms (on average 4 years), which is partly due to the lack of sensitive tools (including imaging) able to pick up the disease early.

  The chosen imaging methods being studied look at the production of saliva in the mouth and the functioning of other glands in the body:
  -Positron emission tomography and computed tomography (PET/CT) scan
  -Magnetic resonance imaging (MRI) scan

  These imaging methods can provide information on how the salivary glands function and are therefore known as functional methods. We wish to confirm the value of these methods by looking at the production of saliva (or spit) in healthy volunteers and patients with pSS. We hope that these methods will help in the development of new therapies in these patients.

  This study will be divided into two groups. These are groups A (Healthy Volunteers) and B (pSS subjects):

  Group A will involve between approximately 4 to 12 healthy volunteers.,

  Group B will involve between approximately 8 to 12 pSS subjects.

  Your participation in this study is not expected to last longer than 11 weeks.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  16/EE/0296

• Date of REC Opinion

  9 Aug 2016

• REC opinion

  Further Information Favourable Opinion