Trial Information
High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma: a Feasibility Study. A Multicentric, Open, Uncontrolled Study
Inclusion Criteria:
- Diagnosis of breast fibroadenoma based on:Clinical examination, Ultrasound image and
mammogram for women older than 35 years, and histology
- Fibroadenoma size superior at 1 cm at its largest dimension (measured by Ultrasound)
Exclusion Criteria:
- Patient pregnant or lactating
- Microcalcifications within the lesion at the mammogram.
- History of breast cancer or history of laser or radiation therapy to the target
breast
- Breast implant in the target breast.
- Fibroadenoma not clearly visible on the ultrasound images (in B mode)
- Patient participating in other trials using drugs or devices
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Outcome Measure:
HIFU induced tissue necrosis assessed by histology of excised gland or reduction volume of fibroadenoma
Outcome Time Frame:
6 months after HIFU treatment
Safety Issue:
No
Principal Investigator
Loïc BOULANGER, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hôpital Jeanne de Flandre, CHU de Lille - FRANCE
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
HIFU/F/FA/Dec2010
NCT ID:
NCT01422629
Start Date:
October 2011
Completion Date:
December 2013
Related Keywords:
- Breast Fibroadenoma
- Breast Fibroadenoma
- High Intensity Focused Ultrasound
- Fibroadenoma