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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Theraclion
ClinicalTrials.gov Identifier:
NCT01331954
First received: April 7, 2011
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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

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 Primary Completion Date: January 2014 (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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331954

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

No publications provided

Responsible Party: Theraclion
ClinicalTrials.gov Identifier: NCT01331954     History of Changes
Other Study ID Numbers: HIFU/BG/FA/Jan2011
Study First Received: April 7, 2011
Last Updated: November 26, 2013
Health Authority: Bulgaria: Bulgarian Drug Agency

Additional relevant MeSH terms:
Fibroadenoma
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 14, 2014