High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma

Breast Fibroadenoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422629
• Other study ID #: HIFU/F/FA/Dec2010
• Status: Completed
• Phase: N/A
• First received: August 18, 2011
• Last updated: April 8, 2014
• Start date: October 2011
• Est. completion date: February 2014

Study information

• Verified date: April 2014
• Source: Theraclion
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Breast Fibroadenoma
• Fibroadenoma

Intervention

Device:
• Ultrasonic ablation device
High Intensity focused ultrasound treatment

Locations

Country	Name	City	State
France	Hôpital Jeanne de Flandre, CHU de Lille 2 Avenue Oscar Lambret	Lille
France	Hôpital Américain de Paris	Neuilly Sur Seine

Sponsors (1)

Lead Sponsor	Collaborator
Theraclion

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIFU induced tissue necrosis assessed by histology of excised gland or reduction volume of fibroadenoma		6 months after HIFU treatment	No
Secondary	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	12 months after HIFU treatment	No
Secondary	- Pain score during the HIFU treatment evaluated by the Visual Analog Scale.		at treatment	No
Secondary	Percentage of patients with Adverse events		at 12 months follow-up	Yes