Fibroadenoma Cancer Benign neoplasm of breast
Conditions
Interventions
Current interventions as of 02/06/2016:
HIFU group
Patients with confirmed fibroadenomas will be administered a local anaesthetic and a coupling media in the form of a
Sponsors
King?'s College London and Guy?'s and St Thomas?' Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients over 18 years of age 2. Fibroadenomata diagnosed according to local hospital protocol; ultrasound alone on patients 25 (Graded B2 or less) 3. Visible on ultrasound (Graded U2/U3) 4. Definitive diagnosis of fibroadenomata confirmed by the breast multi-disciplinary team meeting (MDT)
Exclusion criteria
Exclusion criteria: 1. Lesion with atypia or suspicion of phyllodes (Graded B3 or greater) 2. Pregnant or lactating women 3. History of laser or radiation therapy to the targeted breast
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 02/06/2016: 1. Changes in volume of fibroadenomata as recorded on ultrasound imaging 2. Change in volume in comparison to a control group All outcome measures are measured prior to treatment, straight after treatment, and at 2 weeks, 3, 6 and 12 months follow-up. Previous primary outcome measures: Fibroadenoma size reduction post-treatment on ultrasound imaging | — |
Secondary
| Measure | Time frame |
|---|---|
| Added 02/06/2016: 1. Complications 2. Patient recorded outcome measures (pain symptoms) 3. Mean treatment time 4. Cost-effectiveness All outcome measures are measured prior to treatment, straight after treatment, and at 2 weeks, 3, 6 and 12 months follow-up. | — |
Countries
United Kingdom
Outcome results
None listed