Breast FibroadenomaHIFU-FA-001NCT02078011
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound
A study testing High Intensity Focused Ultrasound in people with Breast Fibroadenoma, run by David R. Brenin, MD at 1 site in United States.
Trial summary
The purpose of this study is to test an investigational device called the Echopulse for treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast tumors that are made of glandular and fibrous breast tissue. These lumps can occur alone, in groups, or as a complex of lumps together. 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?
- High Intensity Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 1 Oct 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
- Diagnosis of fibroadenoma with histological confirmation of fibroadenoma of the breast
- Fibroadenoma is palpable
- Fibroadenoma is 1 cm or greater at its largest dimension and no less than 9 mm in the anterior-posterior dimension
- Fibroadenoma volume is between 2 cc and 10 cc
- Patient must give written informed consent (personally signed and dated) before completing any study-related procedure
Who cannot join
- Patient is pregnant or nursing
- Patient with breast implants in the target breast
- Patient with a breast cyst within the fibroadenoma to be treated
- Patient participating in another clinical trial involving an investigational drug, device or biologic
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
Official title: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): A Feasibility Study
The purpose of this study is to test an investigational device called the Echopulse for treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast tumors that are made of glandular and fibrous breast tissue. These lumps can occur alone, in groups, or as a complex of lumps together. Sometimes women feel these in the breast when doing regular self breast exams, or they may be found during a routine mammogram. Some are small (less than an inch in size), and others are quite large (the size of a lemon or larger).
This is a study about the Echopulse device, a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast). The high intensity focused ultrasound (HIFU) heats the targeted site which causes the cells to die and allows the possibility to treat the fibroadenoma without the need for surgery.
- Conditions
- Breast Fibroadenoma
- Being tested
- 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.
High Intensity Focused UltrasoundDevice
Also called Echopulse
The Echopulse device is a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast).
| Study group | Role | What they receive |
|---|---|---|
| HIFU treatment | Experimental | The high intensity focused ultrasound (HIFU) will be administered to the targeted site to create heat and cause the cells to die Receives: Device: High Intensity Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in volume of fibroadenoma
Fibroadenoma volume with be measured by ultrasound.
Measured: baseline, 3, 6, and 12 months
Size of fibroadenoma
Fibroadenoma will be assessed by physical examination including measurement of tumor size at clinic visits.
Measured: baseline, 3, 6, and 12 months
Patient reported outcomes
Patient-rated pain and patient responses to Satisfaction Questionnaire will be measured at intervals up to 12 months following HIFU treatment session
Measured: up to 12 months
Secondary outcomes (1)
Incidence of adverse events
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startApr 2014
- Primary completion29 Aug 2016
- Study completion1 Oct 2017
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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- David R. Brenin, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Theraclion SAS, Paris, France
- Responsible party
- Sponsor-investigator, David R. Brenin, MD, University of Virginia
- Investigators
- David Brenin, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078011
- Sponsor's protocol ID
- 17277
- Acronym
- HIFU-FA-001
- Status last verified
- May 2018
- First submitted
- 25 Feb 2014
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 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): A Feasibility Study
- ClinicalTrials.gov ID
- NCT02078011
- Acronym / sponsor ID
- HIFU-FA-001 / 17277
- Conditions
- Breast Fibroadenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- David R. Brenin, MDUniversity, hospital or other
- Collaborators
- Theraclion SAS, Paris, France
- Study start
- Apr 2014
- Primary completion
- 29 Aug 2016 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 4 Mar 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 test an investigational device called the Echopulse for treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast tumors that are made of glandular and fibrous breast tissue. These lumps can occur alone, in groups, or as a complex of lumps together. Sometimes women feel these in the breast when doing regular self breast exams, or they may be found during a routine mammogram. Some are small (less than an inch in size), and others are quite large (the size of a lemon or larger).
This is a study about the Echopulse device, a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast). The high intensity focused ultrasound (HIFU) heats the targeted site which causes the cells to die and allows the possibility to treat the fibroadenoma without the need for surgery.
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: High Intensity Focused UltrasoundThe high intensity focused ultrasound (HIFU) will be administered to the targeted site to create heat and cause the cells to die |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of fibroadenoma with histological confirmation of fibroadenoma of the breast
- Fibroadenoma is palpable
- Fibroadenoma is 1 cm or greater at its largest dimension and no less than 9 mm in the anterior-posterior dimension
- Fibroadenoma volume is between 2 cc and 10 cc
- Patient must give written informed consent (personally signed and dated) before completing any study-related procedure
Key exclusion criteria (4 listed)
- Patient is pregnant or nursing
- Patient with breast implants in the target breast
- Patient with a breast cyst within the fibroadenoma to be treated
- Patient participating in another clinical trial involving an investigational drug, device or biologic
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 |
|---|---|---|
| High Intensity Focused UltrasoundAlso: EchopulseThe Echopulse device is a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast). | Device | HIFU treatment |
Primary outcome
Change in volume of fibroadenoma
Time frame: baseline, 3, 6, and 12 months
Fibroadenoma volume with be measured by ultrasound.
Size of fibroadenoma
Time frame: baseline, 3, 6, and 12 months
Fibroadenoma will be assessed by physical examination including measurement of tumor size at clinic visits.
Patient reported outcomes
Time frame: up to 12 months
Patient-rated pain and patient responses to Satisfaction Questionnaire will be measured at intervals up to 12 months following HIFU treatment session
1 secondary outcome
Incidence of adverse events
Time frame: up to 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 7 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.
David Brenin, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Focused Ultrasound in people with Breast Fibroadenoma, run by David R. Brenin, MD at 1 site in United States.
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 5 inclusion and 4 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 7 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 States. 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?
Change in volume of fibroadenoma (time frame: baseline, 3, 6, and 12 months). The study lists 3 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 7 May 2018.