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

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.

Study Overview

• Status: Completed
• Conditions: Breast Fibroadenoma
• Intervention / Treatment: Device: Ultrasonic ablation device

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59000
    • Hôpital Jeanne de Flandre, CHU de Lille 2 Avenue Oscar Lambret
  • Neuilly Sur Seine, France, 92200
    • Hôpital Américain de Paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: High Intensity Focused Ultrasound (HIFU)	Device: Ultrasonic ablation device; High Intensity focused ultrasound treatment; Other Names: TH-One

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume reduction of the fibroadenoma	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	12 months after HIFU treatment
- 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

Collaborators and Investigators

• Sponsor: Theraclion
• Investigators: Principal Investigator: Loïc BOULANGER, MD, Hôpital Jeanne de Flandre, CHU de Lille - FRANCE

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): February 1, 2014
• Study Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: August 18, 2011
• First Submitted That Met QC Criteria: August 23, 2011
• First Posted (ESTIMATE): August 24, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 9, 2014
• Last Update Submitted That Met QC Criteria: April 8, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: High Intensity Focused Ultrasound; Breast Fibroadenoma
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Fibroepithelial; Fibroadenoma
• Other Study ID Numbers: HIFU/F/FA/Dec2010