Clinical Trial: High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma: a Feasibility Study. A Multicentric, Open, Uncontrolled Study

Brief Summary:

This study is a multicentre, open, uncontrolled trial for the observation of histological changes in breast fibroadenoma following high intensity focused ultrasound (HIFU).

This study will be conducted in France in 20 patients with breast fibroadenoma with indication for a surgical resection. The patient will receive an HIFU treatment and 6 months after treatment, the need of the surgery is evaluated.


Detailed Summary:
Sponsor: Theraclion

Current Primary Outcome: HIFU induced tissue necrosis assessed by histology of excised gland or reduction volume of fibroadenoma [ Time Frame: 6 months after HIFU treatment ]

Original Primary Outcome: HIFU induced tissue necrosis assessed by histology of excised gland [ Time Frame: two months after HIFU treatment ]

Current Secondary Outcome:

  • Volume reduction of the fibroadenoma [ Time Frame: 12 months after HIFU treatment ]
    reduction in volume at 2, 4, 6 and 12 months after HIFU session or total regression of the fibroadenoma evaluated with ultrasound just before surgery
  • - Pain score during the HIFU treatment evaluated by the Visual Analog Scale. [ Time Frame: at treatment ]
  • Percentage of patients with Adverse events [ Time Frame: at 12 months follow-up ]


Original Secondary Outcome:

  • - Volume reduction of the fibroadenoma [ Time Frame: two months after HIFU treatment ]
    - Volume reduction of the fibroadenoma measured by ultrasonography 2 months after HIFU treatment, just before surgery
  • - Pain score during the HIFU treatment evaluated by the Visual Analog Scale. [ Time Frame: at treatment ]
  • Percentage of patients with Adverse events [ Time Frame: at 6 months follow-up ]


Information By: Theraclion

Dates:
Date Received: August 18, 2011
Date Started: October 2011
Date Completion:
Last Updated: April 8, 2014
Last Verified: April 2014