Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

Theraclion

Status: Active, not recruiting

Conditions: Breast Fibroadenoma

Treatments: Device: Ultrasonic ablation device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01331954

HIFU/BG/FA/Jan2011

Details and patient eligibility

About

Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast fibroadenoma.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• One breast fibroadenoma with diagnosis based on:

  • Clinical examination
  • Ultrasound image
  • For women older than 35 years: mammogram with BI-RADS score < 3
  • Histologic confirmation by two independent readers

• Fibroadenoma size between 1 cm and 3 cm at its largest dimension (measured by ultrasound)

Exclusion criteria

• Patient pregnant or lactating
• Bi-RADS score > 2 at the mammogram, or microcalcifications within the lesion.
• History of breast cancer or history of laser or radiation therapy to the target breast
• Breast implants
• Breast cyst
• Fibroadenoma not clearly visible on the ultrasound images (in B mode)
• Patient participating in other trials using drugs or devices

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

HIFU

Experimental group

Treatment:

Device: Ultrasonic ablation device