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

Theraclion50 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Fibroadenoma

Interventions

HIFU treatmentDEVICE

HIFU treatment in patients with fibroadenoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Kings College London, Guy's & St Thomas' Hospitals, Department of Research Oncology

London, United Kingdom

Outcomes

Primary Outcomes

Changes in size of fibroadenomata as recorded on ultrasound imaging

Time frame: Month 1, Month 3, Month 12

Secondary Outcomes

Adverse Events

Time frame: Month 1, Month 3, Month 12

Patient recorded outcomes measures

Patient questionnaires and VAS scales

Time frame: Month 1, Month 3, Month 12

Mean treatment time

Time frame: Treatment visit date

Cost-effectiveness

Time frame: 12 months

Data from ClinicalTrials.gov

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