High Intensity Focused Ultrasound for Fibroadenomata (HIFU-F)

  • Research type

    Research Study

  • Full title

    High Intensity Focused Ultrasound for the Treatment of Fibroadenomata (HIFU-F)

  • IRAS ID

    136320

  • Contact name

    Michael Douek

  • Contact email

    michael.douek@kcl.ac.uk

  • Sponsor organisation

    King's College London

  • Research summary

    Fibroadenomata are common benign lesions of the breast resulting from aberrations of normal breast development. The rate of incidence of breast fibroadenomata in women who are examined in breast clinics can be as high as 13 per cent. Their current management consists of confirmation of diagnosis histologically and excision of symptomatic lumps only. Surgical excision is invasive resulting in undesirable scarring and poor cosmetic outcome.

    A high intensity focused ultrasound (HIFU) pulse forms the basis of HIFU therapy. Due to the high local concentration energy, the tissue in a small volume is heated rapidly and a sharp localised “burn“ induced. This allows for “scarless surgery“.

    The current limitation of HIFU is the prolonged treatment times of the procedure. Since a single pulse generates a rather small tissue “burn“, a lot of these single applications have to be applied with an adequate idle time in between to prevent overheating until a fibroadenoma is fully treated.

    We propose to overcome the prolonged treatment times by applying HIFU pulses to the circumferential surface area of lesions rather than their whole volume. We propose to perform this upon a cohort of 50 patients with fibroadenomas using the Echopulse TM (Theraclion, France) HIFU system, which is CE marked for the treatment of breast fibroadenomata.

  • REC name

    London - Bromley Research Ethics Committee

  • REC reference

    13/LO/1221

  • Date of REC Opinion

    27 Aug 2013

  • REC opinion

    Favourable Opinion