Breast FibroadenomaNCT01422629
High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma
A study testing Ultrasonic ablation device in people with Breast Fibroadenoma, run by Theraclion at 2 sites in France.
Trial summary
This study is a multicentre, open, uncontrolled trial for the observation of histological changes in breast fibroadenoma following high intensity focused ultrasound (HIFU). This study will be conducted in France in 20 patients with breast fibroadenoma with indication for a surgical resection. 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?
- Ultrasonic ablation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2011to Feb 2014
- 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
- Diagnosis of breast fibroadenoma based on:Clinical examination, Ultrasound image and mammogram for women older than 35 years, and histology
- Fibroadenoma size superior at 1 cm at its largest dimension (measured by Ultrasound)
Who cannot join
- Patient pregnant or lactating
- Microcalcifications within the lesion at the mammogram.
- History of breast cancer or history of laser or radiation therapy to the target breast
- Breast implant in the target breast.
- Fibroadenoma not clearly visible on the ultrasound images (in B mode)
- Patient participating in other trials using drugs or devices
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Jeanne de Flandre, CHU de Lille 2 Avenue Oscar Lambret
Lille, 59000
Hôpital Américain de Paris
Neuilly-sur-Seine, 92200
About this study
Official title: High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma: a Feasibility Study. A Multicentric, Open, Uncontrolled Study
This study is a multicentre, open, uncontrolled trial for the observation of histological changes in breast fibroadenoma following high intensity focused ultrasound (HIFU).
This study will be conducted in France in 20 patients with breast fibroadenoma with indication for a surgical resection. The patient will receive an HIFU treatment and 6 months after treatment, the need of the surgery is evaluated.
- Conditions
- Breast Fibroadenoma
- Being tested
- Ultrasonic ablation device
- Keywords
- Breast Fibroadenoma, High Intensity Focused Ultrasound
- Medical subject headings
- Fibroadenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic ablation deviceDevice
Also called TH-One
High Intensity focused ultrasound treatment
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Focused Ultrasound (HIFU) | Experimental | Not described Receives: Device: Ultrasonic ablation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIFU induced tissue necrosis assessed by histology of excised gland or reduction volume of fibroadenoma
Measured: 6 months after HIFU treatment
Secondary outcomes (3)
Volume reduction of the fibroadenoma
reduction in volume at 2, 4, 6 and 12 months after HIFU session or total regression of the fibroadenoma evaluated with ultrasound just before surgery
Measured: 12 months after HIFU treatment
- Pain score during the HIFU treatment evaluated by the Visual Analog Scale.
Measured: at treatment
Percentage of patients with Adverse events
Measured: at 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2014
- Study completionFeb 2014
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theraclion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Loïc BOULANGER, MD, Principal investigator, Hôpital Jeanne de Flandre, CHU de Lille - FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422629
- Sponsor's protocol ID
- HIFU/F/FA/Dec2010
- Status last verified
- Apr 2014
- First submitted
- 18 Aug 2011
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma: a Feasibility Study. A Multicentric, Open, Uncontrolled Study
- ClinicalTrials.gov ID
- NCT01422629
- Acronym / sponsor ID
- HIFU/F/FA/Dec2010
- Conditions
- Breast Fibroadenoma
- Keywords
- Breast Fibroadenoma, High Intensity Focused Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- TheraclionIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 24 Aug 2011 (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 is a multicentre, open, uncontrolled trial for the observation of histological changes in breast fibroadenoma following high intensity focused ultrasound (HIFU).
This study will be conducted in France in 20 patients with breast fibroadenoma with indication for a surgical resection. The patient will receive an HIFU treatment and 6 months after treatment, the need of the surgery is evaluated.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Intensity Focused Ultrasound (HIFU) | Experimental | Device: Ultrasonic ablation device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of breast fibroadenoma based on:Clinical examination, Ultrasound image and mammogram for women older than 35 years, and histology
- Fibroadenoma size superior at 1 cm at its largest dimension (measured by Ultrasound)
Key exclusion criteria (6 listed)
- Patient pregnant or lactating
- Microcalcifications within the lesion at the mammogram.
- History of breast cancer or history of laser or radiation therapy to the target breast
- Breast implant in the target breast.
- Fibroadenoma not clearly visible on the ultrasound images (in B mode)
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 |
|---|---|---|
| Ultrasonic ablation deviceAlso: TH-OneHigh Intensity focused ultrasound treatment | Device | High Intensity Focused Ultrasound (HIFU) |
Primary outcome
HIFU induced tissue necrosis assessed by histology of excised gland or reduction volume of fibroadenoma
Time frame: 6 months after HIFU treatment
3 secondary outcomes
Volume reduction of the fibroadenoma
Time frame: 12 months after HIFU treatment
- Pain score during the HIFU treatment evaluated by the Visual Analog Scale.
Time frame: at treatment
Percentage of patients with Adverse events
Time frame: at 12 months follow-up
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 9 Apr 2014.
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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.
Loïc BOULANGER, MD principal investigator
Hôpital Jeanne de Flandre, CHU de Lille - FRANCE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic ablation device in people with Breast Fibroadenoma, run by Theraclion at 2 sites in France.
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 2 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 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
HIFU induced tissue necrosis assessed by histology of excised gland or reduction volume of fibroadenoma (time frame: 6 months after HIFU treatment). 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 9 Apr 2014.