High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma - Full Text View

Sponsor:	Theraclion
Information provided by (Responsible Party):	Theraclion
ClinicalTrials.gov Identifier:	NCT01422629

Purpose

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.

Condition	Intervention
Breast Fibroadenoma	Device: Ultrasonic ablation device

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma: a Feasibility Study. A Multicentric, Open, Uncontrolled Study

Resource links provided by NLM:

MedlinePlus related topics: Ultrasound

U.S. FDA Resources

Further study details as provided by Theraclion:

Primary Outcome Measures:

HIFU induced tissue necrosis assessed by histology of excised gland or reduction volume of fibroadenoma [ Time Frame: 6 months after HIFU treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Volume reduction of the fibroadenoma [ Time Frame: 12 months after HIFU treatment ] [ Designated as safety issue: No ]
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. [ Time Frame: at treatment ] [ Designated as safety issue: No ]
Percentage of patients with Adverse events [ Time Frame: at 12 months follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	October 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: High Intensity Focused Ultrasound (HIFU)	Device: Ultrasonic ablation device High Intensity focused ultrasound treatment Other Name: TH-One

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422629

Contacts

Contact: Loïc BOULANGER, MD

+33 320 44 67 57

loic.boulanger@chru-lille.fr

Locations

France
Hôpital Jeanne de Flandre, CHU de Lille 2 Avenue Oscar Lambret	Not yet recruiting
Lille, France, 59000
Principal Investigator: Loïc BOULANGER, MD
Hôpital Américain de Paris	Recruiting
Neuilly Sur Seine, France, 92200
Principal Investigator: Jean-Noël GUGLIELMINA, Dr
Clinique HARTMANN	Not yet recruiting
Neuilly sur Seine, France, 92200
Contact: Didier BOURGEOIS, MD
Principal Investigator: Didier BOURGEOIS, MD

Sponsors and Collaborators

Theraclion

Investigators

Principal Investigator:

Loïc BOULANGER, MD

Hôpital Jeanne de Flandre, CHU de Lille - FRANCE

More Information

No publications provided

Responsible Party:	Theraclion
ClinicalTrials.gov Identifier:	NCT01422629 History of Changes
Other Study ID Numbers:	HIFU/F/FA/Dec2010
Study First Received:	August 18, 2011
Last Updated:	April 25, 2012
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Theraclion:

Breast Fibroadenoma
High Intensity Focused Ultrasound

Additional relevant MeSH terms:

Fibroadenoma
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 23, 2012