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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Theraclion Identifier:
First received: April 7, 2011
Last updated: April 20, 2016
Last verified: April 2016
Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast fibroadenoma.

Condition Intervention
Breast Fibroadenoma
Device: Ultrasonic ablation device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): a Feasibility Study

Resource links provided by NLM:

Further study details as provided by Theraclion:

Primary Outcome Measures:
  • Reduction of breast fibroadenoma volume at ultrasonography [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIFU Device: Ultrasonic ablation device
One or two HIFU procedures
Other Name: TH-One


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01331954

University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"
Sofia, Bulgaria, 1431
Sponsors and Collaborators
Principal Investigator: Roussanka Kovatcheva, M University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"
  More Information

Responsible Party: Theraclion Identifier: NCT01331954     History of Changes
Other Study ID Numbers: HIFU/BG/FA/Jan2011 
Study First Received: April 7, 2011
Last Updated: April 20, 2016
Health Authority: Bulgaria: Bulgarian Drug Agency

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Glandular and Epithelial processed this record on May 23, 2016