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

Primary Purpose

Breast Fibroadenoma

Status
Unknown status
Phase
Not Applicable
Locations
Bulgaria
Study Type
Interventional
Intervention
Ultrasonic ablation device
Sponsored by
Theraclion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Fibroadenoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIFU

Arm Description

Outcomes

Primary Outcome Measures

Reduction of breast fibroadenoma volume at ultrasonography

Secondary Outcome Measures

Full Information

First Posted
April 7, 2011
Last Updated
May 25, 2018
Sponsor
Theraclion
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1. Study Identification

Unique Protocol Identification Number
NCT01331954
Brief Title
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)
Official Title
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theraclion

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Fibroadenoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIFU
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Ultrasonic ablation device
Other Intervention Name(s)
TH-One
Intervention Description
One or two HIFU procedures
Primary Outcome Measure Information:
Title
Reduction of breast fibroadenoma volume at ultrasonography
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roussanka Kovatcheva, M
Organizational Affiliation
University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria

12. IPD Sharing Statement

Citations:
PubMed Identifier
28331611
Citation
Kovatcheva R, Zaletel K, Vlahov J, Stoinov J. Long-term efficacy of ultrasound-guided high-intensity focused ultrasound treatment of breast fibroadenoma. J Ther Ultrasound. 2017 Mar 16;5:1. doi: 10.1186/s40349-017-0083-1. eCollection 2017.
Results Reference
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Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

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