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Study of ExAblate Focused Ultrasound Ablation of Breast Cancer Under MR Guidance (MRgFUS) and MRI Evaluation of Ablation

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Study of ExAblate Focused Ultrasound Ablation of Breast Cancer Under MR Guidance (MRgFUS) and MRI Evaluation of Ablation

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

Inclusion Criteria:

1. Women age 18 years with invasive breast cancer

2. Patient with contrast-enhanced MR imaging confirming a single focal breast lesion
less than 2 cm in diameter

3. Lesion clearly seen on contrast-enhanced MR and in a treatable location

4. Patient who is willing to undergo and be scheduled for sentinel lymph node biopsy

5. Patient scheduled and consented to surgical (lumpectomy or mastectomy) resection of
the breast cancer

6. Patient with clinical Stage I disease: T1 M0 N0

7. Patient who signs an informed consent form for screening, SLNB, ablation, and
follow-up visits.

Exclusion Criteria:

1. Invasive lobular carcinoma;

2. DCIS without invasive components on core biopsy;

3. Tamoxifen, Aromatase Inhibitors, and Neoadjuvant chemotherapy within 30 days prior to

4. Prior XRT or ablative therapy to the target breast;

5. Patients currently receiving anticoagulation therapy within the previous 14 days;

6. Lesions difficult to target (<1 cm from skin, nipple or the rib cage), as visualized
on pre-therapy MRI;

7. Microcalcifications as the only sign of breast cancer on imaging studies;

8. Extensive intraductal components (EIC) on core biopsy.

9. Patients with breast implants;

10. Patients with prior surgical clips or other markers at the site of the breast tumor;

11. Patients with severe cerebrovascular disease (multiple CVA or CVA within 6 months);

12. hemolytic anemia (hematocrit < 30);

13. Pregnant or lactating, post-partum women;

14. Patient overall health status of ASA >2

15. Patient with active and ongoing infection at any body site;

16. Poor blood glucose control.

17. Severe hypertension

18. Patients with unstable cardiac status

19. Contraindication to MR or ExAblate ablation therapy

20. Patient with history of deep vein thrombosis

21. With history of pulmonary embolism;

22. Patient with sleep apnea;

23. Patient with airway problems;

24. Patient with severe claustrophobia;

25. Patient with non-MRI compatible implanted metal devices;

26. Patient with difficulty lying prone and still for up to 3 hours (180 minutes) in the
MR unit;

27. Patient who cannot fit comfortably in the magnet or patients >250 lbs;

28. Patient with prior reaction to contrast agent;

29. Patient with history of grand mal seizures;

30. Patient with severely impaired renal function with estimated glomerular filtration
rate <30 mL/min/1.73m2 and/or who is on dialysis;

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse Events

Outcome Description:

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

Outcome Time Frame:

5 weeks post treatment

Safety Issue:


Principal Investigator

Hans Kolberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:




Study ID:




Start Date:

June 2011

Completion Date:

October 2014

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Breast tumor
  • stage 1 disease
  • T1 M0 N0
  • Breast Neoplasms