Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU
Not Applicable
Completed
- Conditions
- Breast Fibroadenoma
- Interventions
- Device: HIFU treatment
- Registration Number
- NCT02139683
- Lead Sponsor
- Theraclion
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HIFU treatment HIFU treatment HIFU treatment in patient diagnosed with fibroadenoma
- Primary Outcome Measures
Name Time Method Changes in size of fibroadenomata as recorded on ultrasound imaging Month 1, Month 3, Month 12
- Secondary Outcome Measures
Name Time Method Patient recorded outcomes measures Month 1, Month 3, Month 12 Patient questionnaires and VAS scales
Adverse Events Month 1, Month 3, Month 12 Mean treatment time Treatment visit date Cost-effectiveness 12 months
Trial Locations
- Locations (1)
Kings College London, Guy's & St Thomas' Hospitals, Department of Research Oncology
🇬🇧London, United Kingdom