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Study of ExAblate Focused Ultrasound Ablation of Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01620359
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
InSightec

Tracking Information
First Submitted Date  ICMJE June 13, 2012
First Posted Date  ICMJE June 15, 2012
Last Update Posted Date August 31, 2016
Study Start Date  ICMJE June 2011
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2012)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2012)
MR imaging [ Time Frame: 5 weeks post treatment ]
To estimate the sensitivity of post-ablation MRI in identifying residual disease following ablation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ExAblate Focused Ultrasound Ablation of Breast Cancer
Official Title  ICMJE Study of ExAblate Focused Ultrasound Ablation of Breast Cancer Under MR Guidance (MRgFUS) and MRI Evaluation of Ablation
Brief 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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Device: ExAblate MRgFUS
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 Arms  ICMJE Experimental: ExAblate
Intervention: Device: ExAblate MRgFUS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2016)
14
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2012)
200
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ExAblate.
  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;
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01620359
Other Study ID Numbers  ICMJE BC006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InSightec
Study Sponsor  ICMJE InSightec
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hans Kolberg, MD FUS BOTTROP
PRS Account InSightec
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP