SENTINUS

  • Research type

    Research Study

  • Full title

    SENTINUS: Technical feasibility and diagnostic accuracy of intradermal microbubbles and contrast enhanced ultrasound to identify sentinel lymph node metastases in breast cancer patients following training and mentorship of imaging specialists

  • IRAS ID

    274252

  • Contact name

    Karina Cox

  • Contact email

    karina.cox@nhs.net

  • Sponsor organisation

    Maidstone and Tunbridge Wells NHS Trust

  • Eudract number

    2020-000819-67

  • ISRCTN Number

    ISRCTN10259902

  • Duration of Study in the UK

    1 years, 11 months, 26 days

  • Research summary

    Around 46,000 people are diagnosed with invasive breast cancer every year in the UK. As well as removing the
    tumour in the breast, they are advised to have some or all of their lymph nodes removed from the armpit. As
    most patients have early stage breast cancer, about 70% will not have cancer deposits in the lymph nodes.
    Therefore, many patients risk the potential complications from armpit surgery such as infection, bleeding and
    fluid collection as well as arm swelling, loss of sensation or sometimes pain down the arm, for no benefit. There
    is already a lot of effort to reduce armpit surgery and better use of ultrasound may help to identify patients who
    don’t need this surgery at all.
    We are planning to train specialists from five hospitals to perform a special ultrasound technique, which uses
    microbubbles injected into the breast that can be seen with the ultrasound and followed into the armpit to find the sentinel (or key) lymph nodes. The specialist can then take a needle biopsy to see if the sentinel lymph nodes
    contain cancer deposits. It is important to prove that local specialists can easily and reliably perform the
    microbubbles procedure in the breast clinic. If this research is successful, the plan is to run a larger study to
    make sure that replacing armpit surgery with the microbubbles procedure is safe and doesn’t increase the risk of
    cancer coming back more than the present surgery to the armpit.

  • REC name

    London - Brighton & Sussex Research Ethics Committee

  • REC reference

    20/LO/0833

  • Date of REC Opinion

    22 Jul 2020

  • REC opinion

    Further Information Favourable Opinion