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Intra-operative EMI-137 fluorescence imaging in Breast Cancer

  • Research type

    Research Study

  • Full title

    A pilot study of EMI-137 fluorescence imaging to improve the accuracy of surgical excision in patients with Breast Cancer

  • IRAS ID

    114799

  • Contact name

    Anand David Purushotham

  • Contact email

    Ea-Purushotham@kcl.ac.uk

  • Sponsor organisation

    King's College London/Guy's and St.Thomas' Foundation Trust

  • Eudract number

    2014-003554-13

  • Duration of Study in the UK

    1 years, 4 months, 30 days

  • Research summary

    Wide local excision (WLE) is the type of surgery that is used most often to surgically remove breast cancer. Sentinel Lymph Node Biopsy (SLNB) is a surgical procedure that is done to check if cancer cells have spread to the lymph nodes. There is a lack of techniques that can be used during an operation to check whether all cancer cells have been removed. Therefore, about 1 in 4 breast cancer patients that have a WLE and/or SLNB need to have a second operation to remove remaining cancer cells.

    Repeat surgery has several negative results: poorer cosmetic outcome, delayed adjuvant (post surgery) treatment; increased emotional distress and increased costs. Hence, there is a clear need for developing new techniques to help surgeons remove all cancer cells during the first operation, thus reducing the need for further surgery.

    The aim of this research is to test a new technique that may help surgeons find and remove all cancer cells during surgery. c-Met is a protein found on cell surfaces, including the surfaces of breast cancer cells. The new technique uses a fluorescent tracer (called EMI-137 Injection) which binds to c-Met expressing tumours. The tracer will be injected into patients before surgery and using a fluorescence imaging camera, called the Clinical Spectral Imager, surgeons will locate and remove the cancer cells during surgery. This could lead to complete removal of the cancer and reduce the number of re-operations.
    The study will be an exploratory phase I/II, single centre, study. We are aiming to recruit 40 breast cancer patients at Guy’s and St Thomas’ NHS Foundation Trust.

  • REC name

    London - Chelsea Research Ethics Committee

  • REC reference

    15/LO/0029

  • Date of REC Opinion

    12 Mar 2015

  • REC opinion

    Further Information Favourable Opinion