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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Fibroadenoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

6 months after HIFU treatment

Safety Issue:

No

Principal Investigator

Loïc BOULANGER, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital Jeanne de Flandre, CHU de Lille - FRANCE

Authority:

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

Study ID:

HIFU/F/FA/Dec2010

NCT ID:

NCT01422629

Start Date:

October 2011

Completion Date:

December 2013

Related Keywords:

  • Breast Fibroadenoma
  • Breast Fibroadenoma
  • High Intensity Focused Ultrasound
  • Fibroadenoma

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