Breast FibroadenomaPhase 3NCT00147108
MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas
A Phase 3 study testing ExAblate 2000 in people with Breast Fibroadenoma, run by InSightec at 5 sites in 2 countries.
Trial summary
The primary objective of this pivotal study is to evaluate the safety and efficacy of FUS treatment of breast fibroadenomas. Our hypothesis is that FUS lesion ablation of a fibroadenoma will have the following results: a. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Fibroadenoma
- What is being tested?
- ExAblate 2000
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jan 2003to Oct 2005
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gender: Females only
- Histologic confirmation of breast fibroadenoma by large core (needle gauge range 11-14 ) biopsy.
- Single tumor per breast quadrant
- Tumor clearly visible on non-contrast MRI
- Age > 18 years 3.2.6 Signed informed consent
- Tumor 5 mm or larger as measured on pre-treatment MR.
Who cannot join
- Gender: male
- Focal breast lesion on MRI over 3.5 cm as evaluated by MRI
- Distance from the edge of the breast fibroadenoma to the skin less than 0.5-cm or ribs less than 1 cm.
- Microcalcifications within the lesion
- Known intolerance to the MRI contrast agent (Gadolinium or Magnevist) 3.3.6 Patients on dialysis.
- Hemolytic anemia (hematocrit<30)
Show all 15Show fewer
- Patients with unstable cardiac status including: Unstable angina pectoris on medication Patients with documented myocardial infarction within six months of protocol entry Congestive heart failure requiring medication (other than diuretic) Patients on anti-arrhythmic drugs Severe hypertension (diastolic BP > 100 on medication)
- Patients with cardiac pacemakers
- ASA Score>2
- Severe cerebrovascular disease (multiple CVA or CVA within 6 months) 3.3.12 Individuals who are not able or willing to tolerate the required prolonged stationary prone position during treatment (approximately 3 hrs.) 3.3.13 Patients with breast implants
- Large patients who cannot fit in the magnet (weight>250 pounds), and patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices
- Patients on anti-coagulation therapy, or those with an underlying bleeding disorder.
- Patient has a prior history of breast cancer
- Patient has a prior history of laser or radiation therapy to the target breast
- Patient has a prior history of chemo therapy
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
University MRI
Boca Raton, Florida, 33431
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Cornell Vascular
New York, New York, 10022
Virtua
Voorhees Township, New Jersey, 08043
About this study
Official title: Phase 3 Study of MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas
The primary objective of this pivotal study is to evaluate the safety and efficacy of FUS treatment of breast fibroadenomas. Our hypothesis is that FUS lesion ablation of a fibroadenoma will have the following results: a. lead to a decrease in lesion cross-sectional area of > 50% on palpation, and >65% in lesion volume as measured by MRI (both calculations assume an elliptical shape of the lesion in all 3 dimensions). b. this decrease in size, along with the softening of the treated volume will result in satisfactory clinical results in greater than 50 % of the patients.
Read the detailed description
Many patients are now diagnosed with breast fibroadenomas. These are generally detected during breast self-exams, or annual physicals as a smooth, rubbery, oval/elliptical lump in the breast. These patients then go on to receive mammograms, sonograms and usually a core biopsy for the differential diagnosis of benign disease (fibroadenoma) vs breast cancer. Although fibroadenomas are benign, they can be of great concern to the patient because of their ability to mask the presence of other lumps in the breast, they can be painful, cause a physical deformity of the breast or have other symptoms. The current treatment is surgical excision. Surgical removal is invasive and may be cosmetically undesirable to some patients. It would be advantageous to develop a non-invasive ablative method for treatment of this disease. Measures of the clinical success of patients who elect surgical removal of fibroadenomas are generally subjective, and evaluated primarily by the patient (lack of palpable lesion, pain free, and an acceptable cosmetic result). A non-randomized study is proposed to allow for a more practical approach in subject recruitment. Analysis on safety and efficacy will be performed through the use of MRI evaluation and physical exams.
- Conditions
- Breast Fibroadenoma
- Being tested
- ExAblate 2000
- Keywords
- Breast Cancer
- Medical subject headings
- Fibroadenoma, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate 2000Device
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment/ablation of breast fibroadenoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionAug 2005
- Study completionOct 2005
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.
- More trials run by InSightecThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clare Tempany, M.D., Principal investigator, Brigham and Women's HospitalRobert Min, M.D., Principal investigator, Cornell VascularFred Steinberg, M.D., Principal investigator, University MRIMark DeLaurentis, M.D., Principal investigator, VirtuaHidemi Furusawa, M.D., Principal investigator, Breastopia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147108
- Sponsor's protocol ID
- BF002
- Status last verified
- Sep 2012
- First submitted
- 2 Sep 2005
- Last updated
- 17 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas
- ClinicalTrials.gov ID
- NCT00147108
- Acronym / sponsor ID
- BF002
- Conditions
- Breast Fibroadenoma
- Keywords
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 102 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Aug 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 7 Sep 2005 (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 primary objective of this pivotal study is to evaluate the safety and efficacy of FUS treatment of breast fibroadenomas. Our hypothesis is that FUS lesion ablation of a fibroadenoma will have the following results: a. lead to a decrease in lesion cross-sectional area of > 50% on palpation, and >65% in lesion volume as measured by MRI (both calculations assume an elliptical shape of the lesion in all 3 dimensions). b. this decrease in size, along with the softening of the treated volume will result in satisfactory clinical results in greater than 50 % of the patients.
Detailed description
Many patients are now diagnosed with breast fibroadenomas. These are generally detected during breast self-exams, or annual physicals as a smooth, rubbery, oval/elliptical lump in the breast. These patients then go on to receive mammograms, sonograms and usually a core biopsy for the differential diagnosis of benign disease (fibroadenoma) vs breast cancer. Although fibroadenomas are benign, they can be of great concern to the patient because of their ability to mask the presence of other lumps in the breast, they can be painful, cause a physical deformity of the breast or have other symptoms. The current treatment is surgical excision. Surgical removal is invasive and may be cosmetically undesirable to some patients. It would be advantageous to develop a non-invasive ablative method for treatment of this disease. Measures of the clinical success of patients who elect surgical removal of fibroadenomas are generally subjective, and evaluated primarily by the patient (lack of palpable lesion, pain free, and an acceptable cosmetic result). A non-randomized study is proposed to allow for a more practical approach in subject recruitment. Analysis on safety and efficacy will be performed through the use of MRI evaluation and physical exams.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Gender: Females only
- Histologic confirmation of breast fibroadenoma by large core (needle gauge range 11-14 ) biopsy.
- Single tumor per breast quadrant
- Tumor clearly visible on non-contrast MRI
- Age > 18 years 3.2.6 Signed informed consent
Key exclusion criteria (15 listed)
- Gender: male
- Focal breast lesion on MRI over 3.5 cm as evaluated by MRI
- Distance from the edge of the breast fibroadenoma to the skin less than 0.5-cm or ribs less than 1 cm.
- Microcalcifications within the lesion
- Known intolerance to the MRI contrast agent (Gadolinium or Magnevist) 3.3.6 Patients on dialysis.
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 |
|---|---|---|
| ExAblate 2000 | Device | – |
Primary outcome
treatment/ablation of breast fibroadenoma
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2012.
- Sponsor web pageLink provided by the sponsor.
Related trials for Breast Fibroadenoma
Not yet recruiting
Management of Breast Fibroadenoma: Comparing Observation, Microwave Ablation, and Surgical Excision
Fibroadenoma, Breast Fibroadenoma
Not yet recruiting
Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma: Safety and Cosmetic Outcomes
Breast Fibroadenoma
RecruitingObservational study
ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) - iSono Health
Breast Cancer, Benign Breast Condition
RecruitingPhase 1
Medical Imaging and Focused Ultrasound Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
Fibroadenoma, Breast Cancer Stage I
Not yet recruiting
Value of Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma
Breast Fibroadenoma
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.
Clare Tempany, M.D. principal investigator
Brigham and Women's Hospital
Robert Min, M.D. principal investigator
Cornell Vascular
Fred Steinberg, M.D. principal investigator
University MRI
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ExAblate 2000 in people with Breast Fibroadenoma, run by InSightec at 5 sites in 2 countries.
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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 17 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Japan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
treatment/ablation of breast fibroadenoma. 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 17 Sep 2012; AzTrials last refreshed its copy on 8 Nov 2026.