Back to results

High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma

Primary Purpose

Breast Fibroadenoma

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Ultrasonic ablation device

About this trial

This is an interventional basic science trial for Breast Fibroadenoma focused on measuring Breast Fibroadenoma, High Intensity Focused Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High Intensity Focused Ultrasound (HIFU)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

- Pain score during the HIFU treatment evaluated by the Visual Analog Scale.

Percentage of patients with Adverse events

Full Information

NCT ID

NCT01422629

First Posted

August 18, 2011

Last Updated

April 8, 2014

Sponsor

Theraclion

1. Study Identification

Unique Protocol Identification Number

NCT01422629

Brief Title

High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Theraclion

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Fibroadenoma

Keywords

Breast Fibroadenoma, High Intensity Focused Ultrasound

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High Intensity Focused Ultrasound (HIFU)

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Ultrasonic ablation device

Other Intervention Name(s)

TH-One

Intervention Description

High Intensity focused ultrasound treatment

Primary Outcome Measure Information:

Title

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

Time Frame

6 months after HIFU treatment

Secondary Outcome Measure Information:

Title

Volume reduction of the fibroadenoma

Description

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

Time Frame

12 months after HIFU treatment

Title

- Pain score during the HIFU treatment evaluated by the Visual Analog Scale.

Time Frame

at treatment

Title

Percentage of patients with Adverse events

Time Frame

at 12 months follow-up

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Loïc BOULANGER, MD

Organizational Affiliation

Hôpital Jeanne de Flandre, CHU de Lille - FRANCE

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Lille

ZIP/Postal Code

59000

Country

France

Facility Name

Hôpital Américain de Paris

City

Neuilly Sur Seine

ZIP/Postal Code

92200

Country

France

12. IPD Sharing Statement

Learn more about this trial

High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma

We'll reach out to this number within 24 hrs