High intensity focused ultrasound for the treatment of fibroadenoma

Not Applicable

Completed

• Conditions: Fibroadenoma; Cancer; Benign neoplasm of breast

• Registration Number: ISRCTN76622747
• Lead Sponsor: King?'s College London and Guy?'s and St Thomas?' Hospitals NHS Foundation Trust (UK)

Brief Summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25945250 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27484113 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28854826

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-04
• Study Completion: 2016-10-01
• Last Update Posted: 2 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Patients over 18 years of age
2. Fibroadenomata diagnosed according to local hospital protocol; ultrasound alone on patients <25 and ultrasound plus core-biopsy in 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measures as of 02/06/2016:<br> 1. Changes in volume of fibroadenomata as recorded on ultrasound imaging<br> 2. Change in volume in comparison to a control group<br> All outcome measures are measured prior to treatment, straight after treatment, and at 2 weeks, 3, 6 and 12 months follow-up.<br><br> Previous primary outcome measures:<br> Fibroadenoma size reduction post-treatment on ultrasound imaging<br>

Secondary Outcome Measures

Name	Time	Method
<br> Added 02/06/2016:<br> 1. Complications<br> 2. Patient recorded outcome measures (pain symptoms)<br> 3. Mean treatment time<br> 4. Cost-effectiveness<br> All outcome measures are measured prior to treatment, straight after treatment, and at 2 weeks, 3, 6 and 12 months follow-up.<br>