Efficacy of MR-HIFU Ablation of Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02407613|
Recruitment Status : Active, not recruiting
First Posted : April 3, 2015
Last Update Posted : January 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: Philips Sonalleve MR-HIFU Breast Tumor Therapy System||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
Experimental: MR-HIFU ablation
Ten patients undergo MR-HIFU ablation with the Sonalleve MR-HIFU Breast Tumor Therapy System (Profound Medical). According to a treat-and-resect protocol, these patients also undergo standard therapy consisting of breast cancer surgery 1 to 2 weeks after MR-HIFU treatment (+/- radiotherapy).
Device: Philips Sonalleve MR-HIFU Breast Tumor Therapy System
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) is a completely non-invasive treatment technique. HIFU uses focused ultrasound to achieve temperature rise in the targeted tissue. Real time monitoring of the treatment with MR-thermometry is used to ensure optimal safety.
- Amount of ablated tissue at histopathological examination [ Time Frame: 2-3 weeks (after surgery is performed) ]The amount of ablated tissue and residual viable tumor tissue will be assessed in all tumor slices.
- Presence of non-perfused volumes on DCE-MRI [ Time Frame: 1 week after MR-HIFU ablation ]Efficacy will be assessed by the presence of non-perfused volumes on DCE-MRI. A pre-treatment MRI is used as comparison.
- Number of patients with adverse events [ Time Frame: Approximately 2 to 3 weeks ]Adverse events will be documented. The (possible) relationship with MR-HIFU ablation will be asessed in all cases.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407613
|University Medical Center Utrecht|
|Utrecht, Netherlands, 3584 CX|
|Principal Investigator:||Manon NG Braat, MD||UMC Utrecht|