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High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma

This study is currently recruiting participants.
Verified April 2012 by Theraclion
Sponsor:
Information provided by (Responsible Party):
Theraclion
ClinicalTrials.gov Identifier:
NCT01422629
First received: August 18, 2011
Last updated: April 25, 2012
Last verified: April 2012
History of Changes
  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

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 21, 2013