Back to resultsFeasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU
Primary Purpose
Breast Fibroadenoma
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
HIFU treatment
Sponsored by
About this trial
This is an interventional treatment trial for Breast Fibroadenoma
Eligibility Criteria
Inclusion Criteria:
- Patients >18 years of age
- Fibroadenomata diagnosed according to local hospital protocol; ultrasound alone on patients <25 and ultrasound plus core-biopsy in patients >25 (Graded B2 or less)
- Visible on ultrasound (Graded U2/U3)
- Definitive diagnosis of fibroadenomata confirmed by the Breast multi-disciplinary team meeting (MDT).
Exclusion Criteria:
- Lesion with atypia or suspicion of phyllodes (Graded B3 or greater)
- Pregnant or lactating women
- History of laser or radiation therapy to the targeted breast
Sites / Locations
- Kings College London, Guy's & St Thomas' Hospitals, Department of Research Oncology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HIFU treatment
Arm Description
HIFU treatment in patient diagnosed with fibroadenoma
Outcomes
Primary Outcome Measures
Changes in size of fibroadenomata as recorded on ultrasound imaging
Secondary Outcome Measures
Adverse Events
Patient recorded outcomes measures
Patient questionnaires and VAS scales
Mean treatment time
Cost-effectiveness
Full Information
NCT ID
NCT02139683
First Posted
February 5, 2014
Last Updated
May 25, 2018
Sponsor
Theraclion
Collaborators
King's College London
1. Study Identification
Unique Protocol Identification Number
NCT02139683
Brief Title
Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU
Official Title
High Intensity Focused Ultrasound for the Treatment of Fibroadenomata (HIFU-F)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theraclion
Collaborators
King's College London
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the treatment of fibroadenomata with a circumferential sonification treatment with HIFU..
Detailed Description
Primary endpoint: fibroadenomata size reduction post-treatment on ultrasound imaging.
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
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HIFU treatment
Arm Type
Experimental
Arm Description
HIFU treatment in patient diagnosed with fibroadenoma
Intervention Type
Device
Intervention Name(s)
HIFU treatment
Other Intervention Name(s)
Echopulse
Intervention Description
HIFU treatment in patients with fibroadenoma
Primary Outcome Measure Information:
Title
Changes in size of fibroadenomata as recorded on ultrasound imaging
Time Frame
Month 1, Month 3, Month 12
Secondary Outcome Measure Information:
Title
Adverse Events
Time Frame
Month 1, Month 3, Month 12
Title
Patient recorded outcomes measures
Description
Patient questionnaires and VAS scales
Time Frame
Month 1, Month 3, Month 12
Title
Mean treatment time
Time Frame
Treatment visit date
Title
Cost-effectiveness
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients >18 years of age
Fibroadenomata diagnosed according to local hospital protocol; ultrasound alone on patients <25 and ultrasound plus core-biopsy in patients >25 (Graded B2 or less)
Visible on ultrasound (Graded U2/U3)
Definitive diagnosis of fibroadenomata confirmed by the Breast multi-disciplinary team meeting (MDT).
Exclusion Criteria:
Lesion with atypia or suspicion of phyllodes (Graded B3 or greater)
Pregnant or lactating women
History of laser or radiation therapy to the targeted breast
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Douek, MD
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kings College London, Guy's & St Thomas' Hospitals, Department of Research Oncology
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU
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