Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas
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ClinicalTrials.gov Identifier: NCT02794558 |
Recruitment Status :
Completed
First Posted : June 9, 2016
Last Update Posted : July 1, 2019
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Tracking Information | ||||
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First Submitted Date ICMJE | June 1, 2016 | |||
First Posted Date ICMJE | June 9, 2016 | |||
Last Update Posted Date | July 1, 2019 | |||
Study Start Date ICMJE | June 2005 | |||
Actual Primary Completion Date | March 1, 2019 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Post treatment local recurrence [ Time Frame: 5 years ] 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.
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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 | Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas | |||
Official Title ICMJE | A Clinical Study To Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas | |||
Brief 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 | |||
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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | |||
Intervention ICMJE | Device: ExAblate MRgFUS
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. Other Name: Focused Ultrasound
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Study Arms ICMJE | Experimental: Treatment Arm
Subjects in this arm are treated once with MRgFUS device
Intervention: Device: ExAblate MRgFUS
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
100 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 1, 2019 | |||
Actual Primary Completion Date | March 1, 2019 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02794558 | |||
Other Study ID Numbers ICMJE | BC004 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | InSightec | |||
Study Sponsor ICMJE | InSightec | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | InSightec | |||
Verification Date | June 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |