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Completed

NCT Number: NCT02139683

Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU

The purpose of this study is to assess the treatment of fibroadenomata with a circumferential sonification treatment with HIFU..

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Key information

Conditions

Breast Fibroadenoma Fibroadenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibroepithelial Neoplasms, Fibrous Tissue Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kings College London, Guy's & St Thomas' Hospitals, Department of Research Oncology

London, SE1 9RT, United Kingdom

About this study

Primary endpoint: fibroadenomata size reduction post-treatment on ultrasound imaging.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIFU treatment

Device

HIFU treatment in patients with fibroadenoma

Other names: Echopulse

Primary outcomes

  1. Changes in size of fibroadenomata as recorded on ultrasound imaging

    Time frame: Month 1, Month 3, Month 12

Secondary outcomes

  1. Adverse Events

    Time frame: Month 1, Month 3, Month 12

  2. Patient recorded outcomes measures

    Time frame: Month 1, Month 3, Month 12

    Patient questionnaires and VAS scales

  3. Mean treatment time

    Time frame: Treatment visit date

  4. Cost-effectiveness

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Theraclion

Industry

Collaborators

  • King's College London

Registry information

Official study title

High Intensity Focused Ultrasound for the Treatment of Fibroadenomata (HIFU-F)

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 15, 2014
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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