High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma

NCT01422629 | Completed DMC

• 1 other identifier: HIFU/F/FA/Dec2010
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Fibroadenoma

Keywords

Breast Fibroadenoma; High Intensity Focused Ultrasound

Outcome Measures

Primary Outcomes (1)

• HIFU induced tissue necrosis assessed by histology of excised gland or reduction volume of fibroadenoma

  6 months after HIFU treatment

Secondary Outcomes (3)

• Volume reduction of the fibroadenoma

  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

Study Arms (1)

High Intensity Focused Ultrasound (HIFU)

EXPERIMENTAL

Device: Ultrasonic ablation device

Interventions

Ultrasonic ablation device DEVICE

High Intensity focused ultrasound treatment

Also known as: TH-One

High Intensity Focused Ultrasound (HIFU)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Theraclion: lead

Study Sites (2)

Hôpital Jeanne de Flandre, CHU de Lille 2 Avenue Oscar Lambret

Lille, 59000, France

Location

Hôpital Américain de Paris

Neuilly-sur-Seine, 92200, France

Location

MeSH Terms

Conditions

Fibroadenoma

Condition Hierarchy (Ancestors)

Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial

Study Officials

• Loïc BOULANGER, MD

  Hôpital Jeanne de Flandre, CHU de Lille - FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: August 24, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 9, 2014

Record last verified: 2014-04

Locations

FR (2)