Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU

Breast Fibroadenoma Clinical Trial

Official title:

High Intensity Focused Ultrasound for the Treatment of Fibroadenomata (HIFU-F)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139683
• Other study ID #: HIFU-F
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: May 2018
• Source: Theraclion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the treatment of fibroadenomata with a circumferential sonification treatment with HIFU..

Description:

Primary endpoint: fibroadenomata size reduction post-treatment on ultrasound imaging.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Fibroadenoma
• Fibroadenoma

Intervention

Device:
• HIFU treatment
HIFU treatment in patients with fibroadenoma

Locations

Country	Name	City	State
United Kingdom	Kings College London, Guy's & St Thomas' Hospitals, Department of Research Oncology	London

Sponsors (2)

Lead Sponsor	Collaborator
Theraclion	King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in size of fibroadenomata as recorded on ultrasound imaging		Month 1, Month 3, Month 12
Secondary	Adverse Events		Month 1, Month 3, Month 12
Secondary	Patient recorded outcomes measures	Patient questionnaires and VAS scales	Month 1, Month 3, Month 12
Secondary	Mean treatment time		Treatment visit date
Secondary	Cost-effectiveness		12 months