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

May 25, 2018 updated by: Theraclion

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Kings College London, Guy's & St Thomas' Hospitals, Department of Research Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HIFU treatment
HIFU treatment in patient diagnosed with fibroadenoma
Device: HIFU treatment
HIFU treatment in patients with fibroadenoma
Other Names:
  • Echopulse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in size of fibroadenomata as recorded on ultrasound imaging
Time Frame: Month 1, Month 3, Month 12
Month 1, Month 3, Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness
Time Frame: 12 months
12 months
Adverse Events
Time Frame: Month 1, Month 3, Month 12
Month 1, Month 3, Month 12
Patient recorded outcomes measures
Time Frame: Month 1, Month 3, Month 12
Patient questionnaires and VAS scales
Month 1, Month 3, Month 12
Mean treatment time
Time Frame: Treatment visit date
Treatment visit date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theraclion

Collaborators

King's College London

Investigators

  • Principal Investigator: Michael Douek, MD, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2014

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

February 5, 2014

First Submitted That Met QC Criteria

May 13, 2014

First Posted (ESTIMATE)

May 15, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2018

Last Update Submitted That Met QC Criteria

May 25, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIFU-F

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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