Condition category
Cancer
Date applied
23/01/2014
Date assigned
04/02/2014
Last edited
04/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Fibroadenoma is a common benign lump of the breast present in 1 in 10 women attending breast clinics. The current management of these lumps is patient reassurance once diagnosed and surgical removal only if the lump is growing or is painful. This is because of the risk of undesirable scarring. The aim of this study is to use a high intensity focused ultrasound (HIFU) machine (Echopulse TM) to heat up the breast lump and cause it to shrink. This will eliminate the need for any invasive procedure like surgery and potential undesirable side effects.

Who can participate?
HIFU group: We aim to recruit 50 women over 18 years of age with ultrasound confirmed and symptomatic cases of fibroadenomas. Patients over the age of 25 need a biopsy to confirm the diagnosis of a FAD.
Control group: In addition we aim to recruit an additional 50 patients who are eligible to participate in the study and invite them to come back six months after their FAD diagnosis for an additional ultrasound scan in order to determine the natural change in volume of FAD. These patients do not undergo HIFU treatment.

What does the study involve?
HIFU group: All patients are given local anaesthetic and treated with the ultrasound device as a day case in the outpatient unit. The ultrasound machine is used to image the lump and determine where to treat. Once in the suite patients are placed on their side and local anaesthetic is administered. A gel pad attached to the device is then lowered onto the site of treatment. The HIFU system is used to image the fibroadenomata and set to deliver HIFU treatment. The total treatment time is about 90 minutes. Once the treatment is completed the patient is observed in the discharge suite for 1 hour before being discharged when they meet the local discharge criteria. All patients are reviewed after the procedure and at 2 weeks, 3, 6 and 12 months with a repeat ultrasound scan at each appointment.
Control group: all patients are asked to return to the breast clinic six months after initial diagnosis of their FAD for an additional ultrasound scan.

What are the possible benefits and risks of participating?
HIFU group: The benefit for the patients is that they will not have invasive surgery to treat their fibroadenoma and this will prevent any potential scarring or cosmetic complications. Participants will experience some discomfort after the procedure requiring oral pain relief. The HIFU treatment can result in skin changes and we would expect patients to experience a degree of mild swelling and redness with or without bruising at the treatment site (lasting up to 14 days). Rarely patients may experience minimal changes in skin colour (lasting several months) and superficial skin burns (resolving without any further medical treatment).
Control group: No additional benefits or risks.

Where is the study run from?
Guy'’s NHS Foundation Hospital (UK)

When is the study starting and how long is it expected to run for?
January 2014 to October 2016

Who is funding the study?
Unrestricted educational grant from Theraclion (France)

Who is the main contact?
Mr Muneer Ahmed
02071880721 or 07967006616

Trial website

Contact information

Type

Scientific

Primary contact

Mr Michael Douek

ORCID ID

Contact details

King's College London
Guy’'s & St Thomas'’ Hospitals
Department of Research Oncology
Division of Cancer Studies
3rd Floor Bermondsey Wing
Guy’'s Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Type

Scientific

Additional contact

Ms Mirjam Peek

ORCID ID

Contact details

King's College London
3rd Floor Bermondsey Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 3.0 (05/11/2014) Ref: 13/LO/1221

Study information

Scientific title

High Intensity Focused Ultrasound for the treatment of Fibroadenoma (HIFU-F) Study: a non-randomised study

Acronym

HIFU-F

Study hypothesis

This non-invasive procedure using high intensity focused ultrasound can potentially replace the need for surgical interventional and minimise the risk of scarring and undesirable cosmetic outcomes. In addition to minimising in-patient care requirements.

Ethics approval

NRES Committee London-Bromley, 27/08/2013, ref.: 13/LO/1221

Study design

Non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details above to request a patient information sheet

Condition

Fibroadenoma

Intervention

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 gel pad attached to the device will then be lowered onto the site of treatment. The Echopulse TM will be used to image the lesion in 2 perpendicular dimensions and set to deliver HIFU to the circumferential surface area of the lesion. Once the treatment is completed the patient will be observed in the discharge suite for a period of 1 hour prior to discharge subject to satisfactorily complying with local day case discharge protocols. All patients will be reviewed after the procedure and at 2 weeks, 3, 6 and 12 months with a repeat ultrasound scan at each appointment.

Control group
Patients will undergo an ultrasound scan six months after FAD diagnosis in order to determine the change in volume over time.

Previous interventions:
Patients with confirmed fibroadenomas will be administered a local anaesthetic and a coupling media in the form of a gel pad attached to the device will then be lowered onto the site of treatment. The Echopulse TM will be used to image the lesion in 2 perpendicular dimensions and set to deliver HIFU to the circumferential surface area of the lesion. Once the treatment is completed the patient will be observed in the discharge suite for a period of 1 hour prior to discharge subject to satisfactorily complying with local day case discharge protocols.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

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.

Overall trial start date

01/01/2014

Overall trial end date

01/10/2016

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

50+50 controls

Participant 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

Recruitment start date

28/01/2014

Recruitment end date

01/10/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London, Guy’'s & St Thomas’' Hospitals
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

King’'s College London and Guy’'s and St Thomas’' Hospitals NHS Foundation Trust (UK)

Sponsor details

R&D Department
16th Floor Tower Wing
Guy's Hospital
Great Pond Maze
London
SE1 9RT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Theraclion (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results will be submitted for publication but no timeframe has been set for this.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

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

Publication citations

Additional files

Editorial Notes

04/08/2016: Publication reference added. 02/06/2016: the following changes were made to the trial record: 1. The overall trial end date was changed from 01/10/2014 to 01/10/2016. 2. The target number of participants was changed from '50' to '50+50 controls'.