Breast Fibroadenoma
Conditions
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.
Interventions
DEVICEHIFU treatment
HIFU treatment in patients with fibroadenoma
Sponsors
King's College London
Theraclion
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in size of fibroadenomata as recorded on ultrasound imaging | Month 1, Month 3, Month 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Month 1, Month 3, Month 12 | — |
| Patient recorded outcomes measures | Month 1, Month 3, Month 12 | Patient questionnaires and VAS scales |
| Mean treatment time | Treatment visit date | — |
| Cost-effectiveness | 12 months | — |
Countries
United Kingdom
Outcome results
None listed