Breast FibroadenomaHIFUNCT02011919
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)
A study testing Echopulse in people with Breast Fibroadenoma, run by Theraclion at 1 site in Germany.
Trial summary
This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device Objectives Primary objective: To evaluate the efficacy of HIFU in the treatment of the breast fibroadenoma using the TH-One device Secondary objective… 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
- 27 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2013to Jan 2017
- 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 at least one diagnosed breast fibroadenoma.
- Diagnosis of fibroadenoma must be based on:
- clinical examination,
- women ≤ 40 years of age: ultrasound image alone; women > 40 years of age: ultrasound image and mammogram,
- histological confirmation of fibroadenoma of the breast.
- Patient's fibroadenoma size as determined by ultrasound imaging: the longest diameter is limited to 25 mm.
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- Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to HIFU treatment.
- Patient must be able to understand the nature and the extent of the study and the procédures required and be willing and able to complete the screening and study procedures.
- Patient must give written informed consent (personally signed and dated) before completing any study-related procedure.
Who cannot join
- Patient who is pregnant or breast-feeding.
- Patient with history of ipsilateral breast cancer within 5 years prior to study inclusion or radio therapy to the target breast within 5 years prior to study inclusion.
- Patient with implant on the treated breast.
- Patient with target fibroadenoma pre-treated by cryoablation or interstitial laser therapy within 12 month before recruiting for HIFU.
- Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
- Patient participating in other studies using drugs or medical devices within 3 months prior to study inclusion or during study participation including the follow-up period.
Trial locations and contacts
1 site in 1 country.
About this study
This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device
Objectives Primary objective: To evaluate the efficacy of HIFU in the treatment of the breast fibroadenoma using the TH-One device Secondary objective: To evaluate the tolerability of the HIFU using the TH-One device
- 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
HIFU Under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Echopulse | Other | Echopulse HIFU Receives: Device: Echopulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
FA volume changes from baseline
Measured: Every year during 5 years
Secondary outcomes (9)
Palpability
Lack of palpable lesion
Measured: Every year during 5 years
Pain assessment
Pain free if pain at baseline (pain related to the FA)
Measured: Every year during 5 years
Cosmetic result
Cosmetic result (as judged by investigator)
Measured: Every year during 5 years
Gland vascularisation
Gland vascularisation (compared to baseline) power Doppler at day 7, month 6 and 12, year 2, 3, 4 and 5 after the HIFU session
Measured: Every year during 5 years
Histological outcome
Histological outcome through core needle biopsy after 12 month
Measured: Every year during 5 years
Energy settings
Energy setting to obtain reduction in volume or total regression of the FA at 12 months, 2, 3, 4 and 5 years follow-up
Measured: Every year during 5 years
Breast immobilization
Quality and ease of use of breast immobilization
Measured: Every year during 5 years
Duration of the treatment session
Duration of the treatment session (min)
Measured: Every year during 5 years
Ease of implementation of treatment
Ease of implementation of treatment
Measured: Every year during 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theraclion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011919
- Sponsor's protocol ID
- HIFU / TU / FA
- Acronym
- HIFU
- Status last verified
- May 2018
- First submitted
- 10 Dec 2013
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Hahn M, Fugunt R, Schoenfisch B, Oberlechner E, Gruber IV, Hoopmann U, Roehm C, Helms G, Taran FA, Hartkopf AD, Warzecha H, Wiesinger B, Brucker SY, Boeer B. High intensity focused ultrasound (HIFU) for the treatment of symptomatic breast fibroadenoma. Int J Hyperthermia. 2018;35(1):463-470. doi: 10.1080/02656736.2018.1508757. Epub 2018 Sep 11.
PubMed 30204024
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
- Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)
- ClinicalTrials.gov ID
- NCT02011919
- Acronym / sponsor ID
- HIFU / HIFU / TU / FA
- Conditions
- Breast Fibroadenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- TheraclionIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 13 Dec 2013 (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 is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device
Objectives Primary objective: To evaluate the efficacy of HIFU in the treatment of the breast fibroadenoma using the TH-One device Secondary objective: To evaluate the tolerability of the HIFU using the TH-One device
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Echopulse | Other | 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 (9 listed)
- Female patients 18 years or older with at least one diagnosed breast fibroadenoma.
- Diagnosis of fibroadenoma must be based on:
- Patient's fibroadenoma size as determined by ultrasound imaging: the longest diameter is limited to 25 mm.
- Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to HIFU treatment.
- Patient must be able to understand the nature and the extent of the study and the procédures required and be willing and able to complete the screening and study procedures.
Key exclusion criteria (6 listed)
- Patient who is pregnant or breast-feeding.
- Patient with history of ipsilateral breast cancer within 5 years prior to study inclusion or radio therapy to the target breast within 5 years prior to study inclusion.
- Patient with implant on the treated breast.
- Patient with target fibroadenoma pre-treated by cryoablation or interstitial laser therapy within 12 month before recruiting for HIFU.
- Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
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 |
|---|---|---|
| EchopulseHIFU Under ultrasound guidance | Device | Echopulse |
Primary outcome
FA volume changes from baseline
Time frame: Every year during 5 years
9 secondary outcomes
Palpability
Time frame: Every year during 5 years
Pain assessment
Time frame: Every year during 5 years
Cosmetic result
Time frame: Every year during 5 years
Gland vascularisation
Time frame: Every year during 5 years
Histological outcome
Time frame: Every year during 5 years
Energy settings
Time frame: Every year during 5 years
Breast immobilization
Time frame: Every year during 5 years
Duration of the treatment session
Time frame: Every year during 5 years
Ease of implementation of treatment
Time frame: Every year during 5 years
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.
- Derived from this study: PubMed 30204024Hahn M, Fugunt R, Schoenfisch B, Oberlechner E, Gruber IV, Hoopmann U, Roehm C, Helms G, Taran FA, Hartkopf AD, Warzecha H, Wiesinger B, Brucker SY, Boeer B. High intensity focused ultrasound (HIFU) for the treatment of symptomatic breast fibroadenoma. Int J Hyperthermia. 2018;35(1):463-470. doi: 10.1080/02656736.2018.1508757. Epub 2018 Sep 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Germany.
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 9 inclusion and 6 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 Germany. 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?
FA volume changes from baseline (time frame: Every year during 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02011919, which also lists 1 linked publication.
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.