Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT03560102
Status:
TERMINATED
Last Update Posted:
2021-10-22
First Post:
2018-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer
Sponsor:
Kantonsspital Winterthur KSW
Organization:
Study Overview
Official Title:
Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer: Correlation Between MRI and Histology. Single-Center, Single-Arm, Non-Randomized Trial
Status:
TERMINATED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
recruitment difficulties
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the efficacy of a dedicated Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) unit in ablating breast cancer by comparing MR imaging and pathologic specimen after resection.
Single-center, single-arm, non-randomized trial
Single-center, single-arm, non-randomized trial
Detailed Description:
The dedicated MR-HIFU unit has been shown to be safe and feasible to ablate breast tissue.
The planned study should address the possibility to completely ablate breast cancer with the dedicated breast MR-HIFU unit. The result of the MR-HIFU therapy should be monitored by imaging (contrast enhanced MRI) as well as with histopathological correlation after surgery.
The patient population would consist of female patients with proven breast cancer scheduled for surgical lumpectomy or mastectomy.
The idea is to evaluate a minimal invasive method to treat breast cancer as a potential alternative to surgical resection in the future
The planned study should address the possibility to completely ablate breast cancer with the dedicated breast MR-HIFU unit. The result of the MR-HIFU therapy should be monitored by imaging (contrast enhanced MRI) as well as with histopathological correlation after surgery.
The patient population would consist of female patients with proven breast cancer scheduled for surgical lumpectomy or mastectomy.
The idea is to evaluate a minimal invasive method to treat breast cancer as a potential alternative to surgical resection in the future
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-MD-0021 | OTHER | Swissmedic | View |