NCT01620359

Study of ExAblate Focused Ultrasound Ablation of Breast Cancer

Study of ExAblate Focused Ultrasound Ablation of Breast Cancer Under MR Guidance (MRgFUS) and MRI Evaluation of Ablation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: InSightec · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-06-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2012-06-15
• Last updated: 2016-08-31

Locations

1 site across 1 country: Germany