Clinical Trial: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

Brief Summary: Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast fibroadenoma.

Detailed Summary:
Sponsor: Theraclion

Current Primary Outcome: Reduction of breast fibroadenoma volume at ultrasonography [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

  • Energy setting to obtain reduction in volume or total regression of the fibroadenoma at 12 months follow-up [ Time Frame: 1 year ]
  • Lack of palpable lesion [ Time Frame: 2 years ]
  • Pain free if pain at baseline (pain related to the fibroadenoma) [ Time Frame: 1 year ]
  • Gland vascularisation (compared to baseline) power Doppler at day 7, month 6 and 12 after the HIFU session [ Time Frame: 1 year ]
  • Pain during the HIFU session using a Visual Analog Pain Scale [ Time Frame: 0 month ]
  • Histological outcome through core needle biopsy after 12 month [ Time Frame: 1 year ]
  • Quality and ease of use of breast immobilization [ Time Frame: 1 year ]


Information By: Theraclion

Dates:
Date Received: July 1, 2015
Date Started: October 2013
Date Completion: March 2018
Last Updated: April 26, 2017
Last Verified: April 2017