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High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01422629
First Posted: August 24, 2011
Last Update Posted: April 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Theraclion
  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: None (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:


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 ]

Secondary Outcome Measures:
  • Volume reduction of the fibroadenoma [ Time Frame: 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

  • - Pain score during the HIFU treatment evaluated by the Visual Analog Scale. [ Time Frame: at treatment ]
  • Percentage of patients with Adverse events [ Time Frame: at 12 months follow-up ]

Enrollment: 24
Study Start Date: October 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422629


Locations
France
Hôpital Jeanne de Flandre, CHU de Lille 2 Avenue Oscar Lambret
Lille, France, 59000
Hôpital Américain de Paris
Neuilly Sur Seine, France, 92200
Sponsors and Collaborators
Theraclion
Investigators
Principal Investigator: Loïc BOULANGER, MD Hôpital Jeanne de Flandre, CHU de Lille - FRANCE
  More Information

Responsible Party: Theraclion
ClinicalTrials.gov Identifier: NCT01422629     History of Changes
Other Study ID Numbers: HIFU/F/FA/Dec2010
First Submitted: August 18, 2011
First Posted: August 24, 2011
Last Update Posted: April 9, 2014
Last Verified: April 2014

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