NCT03560102

Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Kantonsspital Winterthur KSW · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Conditions

• Breast Cancer, Invasive Ductal

Interventions

Type	Name	Description
DEVICE	Philips Sonalleve® MR-HIFU Breast Therapy System	The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine.

Timeline

• Start date: 2020-01-13
• Primary completion: 2020-02-05
• Completion: 2020-02-05
• First posted: 2018-06-18
• Last updated: 2021-10-22
• Results posted: 2021-10-22

Locations

1 site across 1 country: Switzerland