ORBiT-Plus Barrett's

  • Research type

    Research Study

  • Full title

    Optical Research for Biopsy Triaging Plus: Infrared analysis of oesophageal tissue specimens to streamline Barrett's surveillance programmes

  • IRAS ID

    259662

  • Contact name

    Gordon Stamp

  • Contact email

    g.stamp@ahlabs.co.uk

  • Sponsor organisation

    BeamLine Diagnostics Ltd. trading as DynamX Medical

  • Duration of Study in the UK

    1 years, 6 months, 0 days

  • Research summary

    Cancer of the oesophagus (gullet) is the sixth most common cause of cancer deaths in the UK. Late stage diagnosis contributes to the poor survival rate associated with the disease. There are two main types of oesophageal cancer; squamous cell carcinoma and oesophageal adenocarcinoma (OAC). OAC is the most common type and therefore a major goal is to detect patients at high risk of developing this cancer and to treat them before the cancer fully develops.
    Barrett’s oesophagus (BE) is the precursory disease to OAC1, where a GP suspects that a patient might be affected by either Barrett’s or cancer of the oesophagus they will be referred to a gastrointestinal specialist for further investigation and diagnosis. The British Society of Gastroenterology (BSG) recommends that people with Barrett’s oesophagus have regular endoscopies to look for changes that could indicate the presence of precancerous cells, this is known as surveillance. The specialist will arrange and perform an endoscopic examination during which tissue samples will be collected and sent to the pathology laboratory for examination. Unfortunately, due to the lack of staff and high volume of samples to process, the waiting time for the results after an endoscopy can be up to 8 weeks2. Many samples sent for analysis will turn out to be healthy. DynamX Medical is addressing the problem by reducing the number of healthy samples that are sent to pathology saving significant time and money to the NHS. This will allow faster diagnosis and more funding for future screening programs.
    DynamX Medical has developed a system that takes advantage of the fact that all molecules within a given sample will absorb different frequencies of light. Dynamx Medical is particularly interested in using infrared light as most biological samples absorb in this region and is non-damaging to the sample. Cancerous/diseased tissue and healthy tissue will contain different biochemicals and give a different infrared signature.
    The DynamX Medical system is completely non-damaging and can enable accurate distinctions to be made between healthy/benign and abnormal tissue samples in just 15 seconds. The non-damaging aspect of the technique is very important as it enables abnormal tissue samples to be sent to the histopathology lab for further analysis. It is also compact (the same footprint as a large laptop) and very easy to use, meaning it can be used by a medically trained person like a nurse or a health care assistant at the point-of-care.
    The purpose of this clinical trial is to further validate our technology that has been previously tested with 200 participants from 4 sites across UK. The study participants will be recruited from those referred for a routine endoscopy procedure.

  • REC name

    South Central - Berkshire B Research Ethics Committee

  • REC reference

    20/SC/0020

  • Date of REC Opinion

    17 Jan 2020

  • REC opinion

    Favourable Opinion