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

Not Applicable

Active, not recruiting

• Conditions: Breast Fibroadenoma
• Interventions: Device: Ultrasonic ablation device

• Registration Number: NCT01331954
• Lead Sponsor: Theraclion

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIFU	Ultrasonic ablation device	-

Primary Outcome Measures

Name	Time	Method
Reduction of breast fibroadenoma volume at ultrasonography	12 months

Trial Locations

Locations (1)

University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"; 🇧🇬 Sofia, Bulgaria