Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-27 @ 7:42 AM
Study NCT ID:
NCT01620359
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2012-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of ExAblate Focused Ultrasound Ablation of Breast Cancer
Sponsor:
InSightec
Organization:
Study Overview
Official Title:
Study of ExAblate Focused Ultrasound Ablation of Breast Cancer Under MR Guidance (MRgFUS) and MRI Evaluation of Ablation
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: