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:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]To estimate the sensitivity of post-ablation MRI in identifying residual disease following ablation.
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||October 2014 (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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620359
|Contact: Heike R Dierfirstname.lastname@example.org|
|Bottrop, Germany, 46236|
|Contact: Heike Rotter-Dier email@example.com|
|Principal Investigator: Jamshid Farahati, MD|
|Principal Investigator:||Hans Kolberg, MD||FUS BOTTROP|