High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01422629

Enrollment

Registered

2011-08-24

Start date

2011-10-31

Completion date

2014-02-28

Last updated

2014-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Fibroadenoma

Keywords

Breast Fibroadenoma, High Intensity Focused Ultrasound

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.

Interventions

DEVICEUltrasonic ablation device

High Intensity focused ultrasound treatment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
HIFU induced tissue necrosis assessed by histology of excised gland or reduction volume of fibroadenoma	6 months after HIFU treatment

Secondary

Measure	Time frame	Description
Volume reduction of the fibroadenoma	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.	at treatment	—
Percentage of patients with Adverse events	at 12 months follow-up	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026