NCT02139683

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

2 years

First QC Date

February 5, 2014

Last Update Submit

May 25, 2018

Conditions

Breast Fibroadenoma

Outcome Measures

Primary Outcomes (1)

  • Changes in size of fibroadenomata as recorded on ultrasound imaging

    Month 1, Month 3, Month 12

Secondary Outcomes (4)

  • Adverse Events

    Month 1, Month 3, Month 12

  • Patient recorded outcomes measures

    Month 1, Month 3, Month 12

  • Mean treatment time

    Treatment visit date

  • Cost-effectiveness

    12 months

Study Arms (1)

HIFU treatment

EXPERIMENTAL

HIFU treatment in patient diagnosed with fibroadenoma

Device: HIFU treatment

Interventions

HIFU treatmentDEVICE

HIFU treatment in patients with fibroadenoma

Also known as: Echopulse
HIFU treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Fibroadenoma

Condition Hierarchy (Ancestors)

Neoplasms, FibroepithelialNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and Epithelial

Study Officials

  • Michael Douek, MD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2014

First Posted

May 15, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations

GB(1)