Breast FibroadenomaNCT02139683
Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU
A study testing HIFU treatment in people with Breast Fibroadenoma, run by Theraclion at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the treatment of fibroadenomata with a circumferential sonification treatment with HIFU.. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Fibroadenoma
- What is being tested?
- HIFU treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Kings College London, Guy's & St Thomas' Hospitals, Department of Research Oncology
London, SE1 9RT
About this study
Official title: 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..
Read the detailed description
Primary endpoint: fibroadenomata size reduction post-treatment on ultrasound imaging.
- Conditions
- Breast Fibroadenoma
- Being tested
- HIFU treatment
- Medical subject headings
- Fibroadenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFU treatmentDevice
Also called Echopulse
HIFU treatment in patients with fibroadenoma
| Study group | Role | What they receive |
|---|---|---|
| HIFU treatment | Experimental | HIFU treatment in patient diagnosed with fibroadenoma Receives: Device: HIFU treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in size of fibroadenomata as recorded on ultrasound imaging
Measured: Month 1, Month 3, Month 12
Secondary outcomes (4)
Adverse Events
Measured: Month 1, Month 3, Month 12
Patient recorded outcomes measures
Patient questionnaires and VAS scales
Measured: Month 1, Month 3, Month 12
Mean treatment time
Measured: Treatment visit date
Cost-effectiveness
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FibroadenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theraclion
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Michael Douek, MD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139683
- Sponsor's protocol ID
- HIFU-F
- Status last verified
- May 2018
- First submitted
- 5 Feb 2014
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Focused Ultrasound for the Treatment of Fibroadenomata (HIFU-F)
- ClinicalTrials.gov ID
- NCT02139683
- Acronym / sponsor ID
- HIFU-F
- Conditions
- Breast Fibroadenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TheraclionIndustry (pharma, biotech, devices)
- Collaborators
- King's College London
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the treatment of fibroadenomata with a circumferential sonification treatment with HIFU..
Detailed description
Primary endpoint: fibroadenomata size reduction post-treatment on ultrasound imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIFU treatment | Experimental | Device: HIFU treatmentHIFU treatment in patient diagnosed with fibroadenoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIFU treatmentAlso: EchopulseHIFU treatment in patients with fibroadenoma | Device | HIFU treatment |
Primary outcome
Changes in size of fibroadenomata as recorded on ultrasound imaging
Time frame: Month 1, Month 3, Month 12
4 secondary outcomes
Adverse Events
Time frame: Month 1, Month 3, Month 12
Patient recorded outcomes measures
Time frame: Month 1, Month 3, Month 12
Mean treatment time
Time frame: Treatment visit date
Cost-effectiveness
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Douek, MD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFU treatment in people with Breast Fibroadenoma, run by Theraclion at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in size of fibroadenomata as recorded on ultrasound imaging (time frame: Month 1, Month 3, Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.