Breast FibroadenomaNCT02488655
Treatment of Breast Fibroadenoma With FastScan HIFU
A study testing Echopulse in people with Breast Fibroadenoma, run by Theraclion at 1 site in Bulgaria.
Trial summary
This study evaluates the efficacy of the HIFU for the treatment of breast fibroadenoma with the FastScan version using assessment of patient experience and adverse event reporting. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Fibroadenoma
- What is being tested?
- Echopulse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBulgaria
- Study dates
- Jun 2015to Dec 2018
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients 18 years or older with one diagnosed breast fibroadenoma.
- Diagnosis of fibroadenoma must be based on :
- clinical examination,
- ultrasound image alone for patients under 35 years old. For women older than 35 years, a mammogram will be performed in addition to ultrasound. The BI-RADS (Breast Imaging, Reporting and Data System) score of this mammogram must be less than 3.
- histologic confirmation after core needle biopsy by two independent readers (biopsy must be performed at least two weeks before therapy unless a microbiopsy has been already done less than 3 months before inclusion visit and histopathology slices are available).
- The requirements for the distance from the skin and the following regions of the fibroadenoma are:
Show all 13Show fewer
- ≤ 23 mm from the posterior border of the fibroadenoma
- ≥ 5 mm from the anterior border of the fibroadenoma
- ≥ 11mm from the focal point of the HIFU treatment. These criteria shall be evaluated immediately prior to treatment once breast is immobilized and potentially compressed
- The rib cage should not be in the prefocal ultrasound path or behind the target fibroadenoma (minimum distance behind the focal point= 10 mm). This criterion shall only be reached in treatment conditions, once breast is immobilized and potentially compressed.
- Patient's fibroadenoma is 1 cm or greater at its largest dimension
- Fibroadenoma is palpable
- Patient has signed a written informed consent.
Who cannot join
- Patient who is pregnant or lactating.
- Patient with a BI-RADS score > 2 at the mammogram, or presence of microcalcifications within the lesion.
- Patient with history of breast cancer or history
- Patient with history of laser or radiation therapy to the target breast
- Patient with breast implants in the target breast
- Patient with a breast cyst
- Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit
- Patient participating in other trials using drugs or devices.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Breast Fibroadenoma With FastScan High Intensity Focused Ultrasound (HIFU)
This study evaluates the efficacy of the HIFU for the treatment of breast fibroadenoma with the FastScan version using assessment of patient experience and adverse event reporting.
Read the detailed description
Echopulse is specially designed, manufactured and CE marked for treating breast fibroadenoma. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.
In a previous european feasibility study performed at 4 sites (France and Bulgaria), 51 fibroadenomas in 42 patients were treated. The HIFU treatment was well tolerated and showed efficacy (mean volume reduction of 72.5% +/-16.7 at 12 months follow-up.
- Conditions
- Breast Fibroadenoma
- Being tested
- Echopulse
- Medical subject headings
- Fibroadenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchopulseDevice
Also called Echopulse HIFU
HIFU Under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Echopulse | Experimental | Echopulse HIFU Receives: Device: Echopulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: 1 day post treatment
Number of participants with adverse events
Measured: 3 days post treatment
Number of participants with adverse events
Measured: 7 days post treatment
Change from Baseline volume of the fibroadenoma at 6 months
Measured: 6 months post treament
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day
Measured: 1 day post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days
Measured: 3 days post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days
Measured: 7 days post treatment
Patient satisfaction questionnaire
Measured: 6 months post treatment
Secondary outcomes (6)
Number of participants with absence of palpable lesion
Measured: 3 months post treatment
Number of participants with absence of palpable lesion
Measured: 6 months post treatment
Patient Cosmetic evaluation as measured by questionnaire
Measured: 6 months post treatment
Investigator rated evaluation of the device
Measured: Post treatment Day 0
Change from Baseline gland vascularization at 3 months
Measured: 3 months post treatment
Change from Baseline gland vascularization at 6 months
Measured: 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2018
- Study completionDec 2018
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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theraclion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roussanka Kovatcheva, Prof., Principal investigator, roussanka_kov@yahoo.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488655
- Sponsor's protocol ID
- HIFU/BG/FA/FS/2015
- Status last verified
- Oct 2021
- First submitted
- 24 Jun 2015
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Breast Fibroadenoma With FastScan High Intensity Focused Ultrasound (HIFU)
- ClinicalTrials.gov ID
- NCT02488655
- Acronym / sponsor ID
- HIFU/BG/FA/FS/2015
- Conditions
- Breast Fibroadenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- TheraclionIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 2 Jul 2015 (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.
This study evaluates the efficacy of the HIFU for the treatment of breast fibroadenoma with the FastScan version using assessment of patient experience and adverse event reporting.
Detailed description
Echopulse is specially designed, manufactured and CE marked for treating breast fibroadenoma. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.
In a previous european feasibility study performed at 4 sites (France and Bulgaria), 51 fibroadenomas in 42 patients were treated. The HIFU treatment was well tolerated and showed efficacy (mean volume reduction of 72.5% +/-16.7 at 12 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Echopulse | Experimental | Device: EchopulseEchopulse HIFU |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female patients 18 years or older with one diagnosed breast fibroadenoma.
- Diagnosis of fibroadenoma must be based on :
- The requirements for the distance from the skin and the following regions of the fibroadenoma are:
- The rib cage should not be in the prefocal ultrasound path or behind the target fibroadenoma (minimum distance behind the focal point= 10 mm). This criterion shall only be reached in treatment conditions, once breast is immobilized and potentially compressed.
- Patient's fibroadenoma is 1 cm or greater at its largest dimension
Key exclusion criteria (8 listed)
- Patient who is pregnant or lactating.
- Patient with a BI-RADS score > 2 at the mammogram, or presence of microcalcifications within the lesion.
- Patient with history of breast cancer or history
- Patient with history of laser or radiation therapy to the target breast
- Patient with breast implants in the target 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 |
|---|---|---|
| EchopulseAlso: Echopulse HIFUHIFU Under ultrasound guidance | Device | Echopulse |
Primary outcome
Number of participants with adverse events
Time frame: 1 day post treatment
Number of participants with adverse events
Time frame: 3 days post treatment
Number of participants with adverse events
Time frame: 7 days post treatment
Change from Baseline volume of the fibroadenoma at 6 months
Time frame: 6 months post treament
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day
Time frame: 1 day post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days
Time frame: 3 days post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days
Time frame: 7 days post treatment
Patient satisfaction questionnaire
Time frame: 6 months post treatment
6 secondary outcomes
Number of participants with absence of palpable lesion
Time frame: 3 months post treatment
Number of participants with absence of palpable lesion
Time frame: 6 months post treatment
Patient Cosmetic evaluation as measured by questionnaire
Time frame: 6 months post treatment
Investigator rated evaluation of the device
Time frame: Post treatment Day 0
Change from Baseline gland vascularization at 3 months
Time frame: 3 months post treatment
Change from Baseline gland vascularization at 6 months
Time frame: 6 months post treatment
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 19 Oct 2021.
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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.
Roussanka Kovatcheva, Prof. principal investigator
roussanka_kov@yahoo.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echopulse in people with Breast Fibroadenoma, run by Theraclion at 1 site in Bulgaria.
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 13 inclusion and 8 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 19 Oct 2021. 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 Bulgaria. 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?
Number of participants with adverse events (time frame: 1 day post treatment). The study lists 8 primary outcomes in all. 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 19 Oct 2021.