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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: ExAblate MRgFUS||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Study To Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||March 1, 2019|
|Actual Study Completion Date :||March 1, 2019|
Experimental: Treatment Arm
Subjects in this arm are treated once with MRgFUS device
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
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794558
|Principal Investigator:||Hidemi Furasawa, MD||Managing Director at Breastopia Namba Hospital|