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
results.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
5 weeks post treatment
Yes
Hans Kolberg, MD
Principal Investigator
FUS BOTTROP
Germany:BfArm
BC006
NCT01620359
June 2011
October 2014
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