title: High-intensity focused ultrasound for the treatment of fibroadenomata (HIFU-F) study.
abstract: BACKGROUND
  Breast fibroadenomata (FAD) are the most common benign lesions in women. For palpable lesions, there are currently three standard treatment options: reassurance (with or without follow-up), vacuum-assisted mammotomy (VAM) or surgical excision. High-intensity focused ultrasound (HIFU) ablation has been used in the treatment of FAD. The drawback of HIFU is its prolonged treatment duration. The aim of this trial is to evaluate circumferential HIFU treatment for the effective ablation of FAD with a reduced treatment time.
  
  
  METHODS
  Fifty patients (age ≥18 years) will be recruited with symptomatic FAD, visible on ultrasound (US, grade U2 benign). In patients ≥25 years, cytology or histology will be performed to confirm the diagnosis of a FAD. These patients will receive HIFU treatment using the US-guided Echopulse device (Theraclion Ltd., Malakoff, France) under local anaesthesia. An additional 50 patients will be recruited and contacted 6 months after discharge from the breast clinic. These patients will be offered an US scan to determine the change in size of their FAD. This natural change in size will be compared to the decrease in size after HIFU treatment. Secondary outcome measures include post-treatment complications, patient recorded outcome measures, mean treatment time and cost analysis.
  
  
  BACKGROUND
  Current Controlled Trials: ISRCTN76622747.
authors.affiliation: Research Oncology, Division of Cancer Studies, King's College London, Guy's Hospital Campus, Great Maze Pond, London, SE1 9RT Great Britain UK.
authors.forename: Mirjam C L
authors.initials: MC
authors.lastname: Peek
authors.affiliation: Research Oncology, Division of Cancer Studies, King's College London, Guy's Hospital Campus, Great Maze Pond, London, SE1 9RT Great Britain UK.
authors.forename: Muneer
authors.initials: M
authors.lastname: Ahmed
authors.affiliation: Research Oncology, Division of Cancer Studies, King's College London, Guy's Hospital Campus, Great Maze Pond, London, SE1 9RT Great Britain UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Douek
keywords: Benign breast disease; Fibroadenoma; Non-invasive treatment; Ultrasound-guided high-intensity focused ultrasound (HIFU)