High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma

Not Applicable

Completed

• Conditions: Breast Fibroadenoma
• Interventions: Device: Ultrasonic ablation device

• Registration Number: NCT01422629
• Lead Sponsor: Theraclion

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 Description

Not available

Study Timeline

• Study First Submitted: 2011-08-18
• Study First Submitted QC: 2011-08-23
• Study First Posted: 2011-08-24
• Study Start: 2011-10
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High Intensity Focused Ultrasound (HIFU)	Ultrasonic ablation device	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
- 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
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

Trial Locations

Locations (2)

Hôpital Américain de Paris; 🇫🇷 Neuilly Sur Seine, France

Hôpital Jeanne de Flandre, CHU de Lille 2 Avenue Oscar Lambret; 🇫🇷 Lille, France