Breast CancerPhase 2NCT01620359
Study of ExAblate Focused Ultrasound Ablation of Breast Cancer
A Phase 2 study testing ExAblate MRgFUS in people with Breast Cancer, run by InSightec at 1 site in Germany.
Trial summary
The goal of this prospective, non-randomized, single-arm, multi site, international study is to develop data to evaluate the safety and effectiveness of the ExAblate MRgFUS system in the ablation of breast cancer and of MRI. 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
- 14 participants
- Where
- 1 siteGermany
- Study dates
- 24 Nov 2010to 14 Apr 2014
- Phase
- Phase 2
- 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 invasive breast cancer
- Patient with contrast-enhanced MR imaging confirming a single focal breast lesion less than 2 cm in diameter
- Lesion clearly seen on contrast-enhanced MR and in a treatable location
- Patient who is willing to undergo and be scheduled for sentinel lymph node biopsy
- Patient scheduled and consented to surgical (lumpectomy or mastectomy) resection of the breast cancer
- Patient with clinical Stage I disease: T1 M0 N0
- Patient who signs an informed consent form for screening, SLNB, ablation, and follow-up visits.
Who cannot join
- Invasive lobular carcinoma;
- DCIS without invasive components on core biopsy;
- Tamoxifen, Aromatase Inhibitors, and Neoadjuvant chemotherapy within 30 days prior to ExAblate.
- Prior XRT or ablative therapy to the target breast;
- Patients currently receiving anticoagulation therapy within the previous 14 days;
- Lesions difficult to target (<1 cm from skin, nipple or the rib cage), as visualized on pre-therapy MRI;
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- Microcalcifications as the only sign of breast cancer on imaging studies;
- Extensive intraductal components (EIC) on core biopsy.
- Patients with breast implants;
- Patients with prior surgical clips or other markers at the site of the breast tumor;
- Patients with severe cerebrovascular disease (multiple CVA or CVA within 6 months);
- hemolytic anemia (hematocrit < 30);
- Pregnant or lactating, post-partum women;
- Patient overall health status of ASA >2
- Patient with active and ongoing infection at any body site;
- Poor blood glucose control.
- Severe hypertension
- Patients with unstable cardiac status
- Contraindication to MR or ExAblate ablation therapy
- Patient with history of deep vein thrombosis
- With history of pulmonary embolism;
- Patient with sleep apnea;
- Patient with airway problems;
- Patient with severe claustrophobia;
- Patient with non-MRI compatible implanted metal devices;
- Patient with difficulty lying prone and still for up to 3 hours (180 minutes) in the MR unit;
- Patient who cannot fit comfortably in the magnet or patients >250 lbs;
- Patient with prior reaction to contrast agent;
- Patient with history of grand mal seizures;
- Patient with severely impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2 and/or who is on dialysis;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of ExAblate Focused Ultrasound Ablation of Breast Cancer Under MR Guidance (MRgFUS) and MRI Evaluation of Ablation
The goal of this prospective, non-randomized, single-arm, multi site, international study is to develop data to evaluate the safety and effectiveness of the ExAblate MRgFUS system in the ablation of breast cancer and of MRI.
The goal of MRgFUS ablation of breast cancer is to plan and ablate the entire tumor volume in a treatable and device accessible location.
Read the detailed description
In this international, non-randomized, single-arm study, a total of 200 patients with a positive diagnosis of invasive breast cancer with a scheduled surgical resection will be enrolled into the trial. Eligible participants will be evaluated and treated with ExAblate breast ablation prior to their planned definitive surgical treatment. After the 10 to 21 days post ExAblate therapy, study participants will have another contrast-enhanced MR imaging examination. Their planned tumor excision will then be completed no later than 14 days from the contrast-enhanced, post ExAblate procedure MR imaging examination. Additionally, the end points of the study will be compared against the CORE Pathology Lab results.
- Conditions
- Breast Cancer
- Being tested
- ExAblate MRgFUS
- Keywords
- Breast cancer, Breast tumor, stage 1 disease, T1 M0 N0
- Medical subject headings
- Breast Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate MRgFUSDevice
100% ablation of an up-to-2-cm breast cancer visible on an contrast-enhanced MRI with 5-10 mm margins around the primary tumor
| Study group | Role | What they receive |
|---|---|---|
| ExAblate | Experimental | Not described Receives: Device: ExAblate MRgFUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
To evaluate the incidence and severity of the ExAblate MRgFUS device-related complications to establish the safety profile of the ExAblate ablation of breast cancer visible on contrast-enhanced MRI with 5-10 mm margins around the primary tumor
Measured: 5 weeks post treatment
Histopathological analyses
To estimate the effectiveness of ExAblate MRgFUS to ablate 100% of an up-to-2-cm breast cancer visible on an contrast-enhanced MRI with 5-10 mm margins around the primary tumor.
Measured: 5 weeks post treatment
Secondary outcomes (1)
MR imaging
To estimate the sensitivity of post-ablation MRI in identifying residual disease following ablation.
Measured: 5 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study start24 Nov 2010
- Primary completion14 Apr 2014
- Study completion14 Apr 2014
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans Kolberg, MD, Principal investigator, FUS BOTTROP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620359
- Sponsor's protocol ID
- BC006
- Status last verified
- Sep 2026
- First submitted
- 13 Jun 2012
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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
- Study of ExAblate Focused Ultrasound Ablation of Breast Cancer Under MR Guidance (MRgFUS) and MRI Evaluation of Ablation
- ClinicalTrials.gov ID
- NCT01620359
- Acronym / sponsor ID
- BC006
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Breast tumor, stage 1 disease, T1 M0 N0
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2010 (actual)
- Primary completion
- 14 Apr 2014 (actual)
- Study completion
- 14 Apr 2014 (actual)
- First posted
- 15 Jun 2012 (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 goal of this prospective, non-randomized, single-arm, multi site, international study is to develop data to evaluate the safety and effectiveness of the ExAblate MRgFUS system in the ablation of breast cancer and of MRI.
The goal of MRgFUS ablation of breast cancer is to plan and ablate the entire tumor volume in a treatable and device accessible location.
Detailed description
In this international, non-randomized, single-arm study, a total of 200 patients with a positive diagnosis of invasive breast cancer with a scheduled surgical resection will be enrolled into the trial. Eligible participants will be evaluated and treated with ExAblate breast ablation prior to their planned definitive surgical treatment. After the 10 to 21 days post ExAblate therapy, study participants will have another contrast-enhanced MR imaging examination. Their planned tumor excision will then be completed no later than 14 days from the contrast-enhanced, post ExAblate procedure MR imaging examination. Additionally, the end points of the study will be compared against the CORE Pathology Lab results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExAblate | Experimental | Device: ExAblate MRgFUS |
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 invasive breast cancer
- Patient with contrast-enhanced MR imaging confirming a single focal breast lesion less than 2 cm in diameter
- Lesion clearly seen on contrast-enhanced MR and in a treatable location
- Patient who is willing to undergo and be scheduled for sentinel lymph node biopsy
- Patient scheduled and consented to surgical (lumpectomy or mastectomy) resection of the breast cancer
Key exclusion criteria (30 listed)
- Invasive lobular carcinoma;
- DCIS without invasive components on core biopsy;
- Tamoxifen, Aromatase Inhibitors, and Neoadjuvant chemotherapy within 30 days prior to ExAblate.
- Prior XRT or ablative therapy to the target breast;
- Patients currently receiving anticoagulation therapy within the previous 14 days;
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 MRgFUS100% ablation of an up-to-2-cm breast cancer visible on an contrast-enhanced MRI with 5-10 mm margins around the primary tumor | Device | ExAblate |
Primary outcome
Adverse Events
Time frame: 5 weeks post treatment
To evaluate the incidence and severity of the ExAblate MRgFUS device-related complications to establish the safety profile of the ExAblate ablation of breast cancer visible on contrast-enhanced MRI with 5-10 mm margins around the primary tumor
Histopathological analyses
Time frame: 5 weeks post treatment
To estimate the effectiveness of ExAblate MRgFUS to ablate 100% of an up-to-2-cm breast cancer visible on an contrast-enhanced MRI with 5-10 mm margins around the primary tumor.
1 secondary outcome
MR imaging
Time frame: 5 weeks post treatment
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.
- Sponsor's websiteLink provided by the sponsor.
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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.
Hans Kolberg, MD principal investigator
FUS BOTTROP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ExAblate MRgFUS in people with Breast Cancer, run by InSightec 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 7 inclusion and 30 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Adverse Events (time frame: 5 weeks post treatment). The study lists 2 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 8 Sep 2026.