Breast CancerNCT02794558
Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas
A study testing ExAblate MRgFUS in people with Breast Cancer, run by InSightec at 1 site in Japan.
Trial summary
Non-randomized, Single Arm Clinical study to Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ExAblate MRgFUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteJapan
- Study dates
- 24 May 2005to 1 Mar 2019
- 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
- Women age ≥ 18 years with - breast cancer proven by 14-20 G. core needle biopsy of the breast lesion.
- No evidence of cancer at the sentinel/ Axillary node
- Women in whom breast MR imaging identifies a single focal well-demarcated breast lesion less than or equal to 1.5 cm in diameter with stage T1, N0, M0 disease.
- Patient received neoadjuvant care for 4 weeks such as: Hormone replacement therapy or Tamoxifen is permissible where the tumor is less than or equal to 1.5 before neoadjuvant therapy
- Able and willing to give consent and able to attend all study visits.
- Able to communicate sensations during the MRgFUS procedure.
- Life expectancy of 5 years or more.
Who cannot join
- Breast cancer which was diagnosed by incisional / excisional biopsy
- Contraindication to MRI (non-MRI compatible implanted metal devices).
- Pregnant or lactating post partum women.
- Prior XRT or laser or cryo-therapy to the target breast.
- Difficulty lying prone and still for up to 210 minutes in the MR unit, e.g., COPD, heart disease, lung disease, sleep apnea or airway problems, severe asthma, severe arthritis, severe claustrophobia.
- Patients with unstable cardiac status including:
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- Unstable angina pectoris on medication.
- Patients with documented myocardial infarction within six months of protocol entry.
- Congestive heart failure requiring medication.
- Patients on anti-arrhythmic drugs.
- Severe hypertension (diastolic BP > 100 on medication).
- Patients with cardiac pacemakers.
- Immunosuppressed patients, e.g., patients receiving steroids or other immunosuppressive medication, insulin-dependent diabetes mellitus, collagen vascular disease.
- Patients receiving chemotherapy
- Patients with history of grand mal seizures, severe cerebrovascular disease (multiple CVA or CVA within 6 months), hemolytic anemia (hematocrit < 30), or patients on dialysis.
- Patients currently receiving anticoagulation therapy.
- Large patients who cannot fit comfortably in the magnet, or patients > 100Kg.
- Lesions difficult to target (<1 cm from skin, nipple-areola complex or the ribcage), as visualized on pre-therapy MRI.
- Microcalcifications as the only sign of breast cancer on imaging studies.
- Patients with breast implants.
- Prior reaction to gadolinium-based contrast agent
- Prior radiation to the breast, which is about to be treated.
- Evidence of tumor at any location other then the targeted lesion.
- Histological type of invasive micropapillary carcinoma because of cancer displacement by the needle
- Mucinous carcinoma which was diagnosed by core needle biopsy because of needle cancer displacement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study To Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas
Non-randomized, Single Arm Clinical study to Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas
Read the detailed description
Study specific aim is to Coagulate the tissue volume of a proven breast cancer with MRgFUS and Collect post treatment follow-up clinical and radiological data for a period of 5 years following MRgFUS for breast cancer.
Safety of the treatment will be evaluated by recording and assessing the incidence and severity of device- related complications from the first visit through the 5 years follow-up period.
Secondary objective of this study is to evaluate post treatment local recurrence in the same quadrant or less then 4cm from the periphery of the treated lesion, during a 5 year period following the MRgFUS treatment.
Women with breast cancer in whom breast MR imaging identifies a single focal breast lesion up to 1.5 cm in diameter will be eligible for the study.
- Conditions
- Breast Cancer
- Being tested
- ExAblate MRgFUS
- Keywords
- Breast Cancer, MRgFus, Focused Ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate MRgFUSDevice
Also called Focused Ultrasound
MR images of the breast will be obtained for lesion localization purposes. The breast surgeon or the radiologist will make a treatment plan or map. Sonication at therapeutic power level will be performed on multiple overlapping points successively until sonication of the target volume has been completed.
Follow-up evaluation will be made within 14 to 21 days after the MRgFUS treatment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Subjects in this arm are treated once with MRgFUS device Receives: Device: ExAblate MRgFUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Adverse events
Safety of the treatment will be evaluated by recording and assessing the incidence and severity of device- related complications
Measured: 5 years
Secondary outcomes (1)
Post treatment local recurrence
new appearance of a malignant tissue of the same type as the treated primary breast lesion, in the same quadrant or less then 4cm from the periphery of the treated lesion, during a 5 year period following the MRgFUS treatment.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study start24 May 2005
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hidemi Furasawa, MD, Principal investigator, Managing Director at Breastopia Namba Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794558
- Sponsor's protocol ID
- BC004
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2016
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study To Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas
- ClinicalTrials.gov ID
- NCT02794558
- Acronym / sponsor ID
- BC004
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, MRgFus, Focused Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- 24 May 2005 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 9 Jun 2016 (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.
Non-randomized, Single Arm Clinical study to Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas
Detailed description
Study specific aim is to Coagulate the tissue volume of a proven breast cancer with MRgFUS and Collect post treatment follow-up clinical and radiological data for a period of 5 years following MRgFUS for breast cancer.
Safety of the treatment will be evaluated by recording and assessing the incidence and severity of device- related complications from the first visit through the 5 years follow-up period.
Secondary objective of this study is to evaluate post treatment local recurrence in the same quadrant or less then 4cm from the periphery of the treated lesion, during a 5 year period following the MRgFUS treatment.
Women with breast cancer in whom breast MR imaging identifies a single focal breast lesion up to 1.5 cm in diameter will be eligible for the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: ExAblate MRgFUSSubjects in this arm are treated once with MRgFUS device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women age ≥ 18 years with - breast cancer proven by 14-20 G. core needle biopsy of the breast lesion.
- No evidence of cancer at the sentinel/ Axillary node
- Women in whom breast MR imaging identifies a single focal well-demarcated breast lesion less than or equal to 1.5 cm in diameter with stage T1, N0, M0 disease.
- Patient received neoadjuvant care for 4 weeks such as: Hormone replacement therapy or Tamoxifen is permissible where the tumor is less than or equal to 1.5 before neoadjuvant therapy
- Able and willing to give consent and able to attend all study visits.
Key exclusion criteria (25 listed)
- Breast cancer which was diagnosed by incisional / excisional biopsy
- Contraindication to MRI (non-MRI compatible implanted metal devices).
- Pregnant or lactating post partum women.
- Prior XRT or laser or cryo-therapy to the target breast.
- Difficulty lying prone and still for up to 210 minutes in the MR unit, e.g., COPD, heart disease, lung disease, sleep apnea or airway problems, severe asthma, severe arthritis, severe claustrophobia.
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 MRgFUSAlso: Focused UltrasoundMR images of the breast will be obtained for lesion localization purposes. The breast surgeon or the radiologist will make a treatment plan or map. Sonication at therapeutic power level will be performed on multiple overlapping points successively until sonication of the target volume has been completed. Follow-up evaluation will be made within 14 to 21 days after the MRgFUS treatment. | Device | Treatment Arm |
Primary outcome
Incidence and severity of Adverse events
Time frame: 5 years
Safety of the treatment will be evaluated by recording and assessing the incidence and severity of device- related complications
1 secondary outcome
Post treatment local recurrence
Time frame: 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 8 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Hidemi Furasawa, MD principal investigator
Managing Director at Breastopia Namba Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExAblate MRgFUS in people with Breast Cancer, run by InSightec at 1 site in Japan.
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 7 inclusion and 25 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 8 Sep 2026. 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 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.
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?
Incidence and severity of Adverse events (time frame: 5 years). 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 8 Sep 2026.