Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU
Not Applicable
Completed
- Conditions
- Breast Fibroadenoma
- 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
- 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 Adverse Events Month 1, Month 3, Month 12 Mean treatment time Treatment visit date Cost-effectiveness 12 months Patient recorded outcomes measures Month 1, Month 3, Month 12 Patient questionnaires and VAS scales
Trial Locations
- Locations (1)
Kings College London, Guy's & St Thomas' Hospitals, Department of Research Oncology
🇬🇧London, United Kingdom
Kings College London, Guy's & St Thomas' Hospitals, Department of Research Oncology🇬🇧London, United Kingdom