Study of ExAblate Focused Ultrasound Ablation of Breast Cancer
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Study of ExAblate Focused Ultrasound Ablation of Breast Cancer Under MR Guidance (MRgFUS) and MRI Evaluation of Ablation|
- 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.
- MR imaging [ Time Frame: 5 weeks post treatment ]To estimate the sensitivity of post-ablation MRI in identifying residual disease following ablation.
|Study Start Date:||June 2011|
|Study Completion Date:||July 2016|
|Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620359
|Bottrop, Germany, 46236|
|Principal Investigator:||Hans Kolberg, MD||FUS BOTTROP|