High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma

Theraclion

Status: Completed

Conditions: Breast Fibroadenoma

Treatments: Device: Ultrasonic ablation device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01422629

HIFU/F/FA/Dec2010

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

High Intensity Focused Ultrasound (HIFU)

Experimental group

Treatment:

Device: Ultrasonic ablation device