Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03560102|
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : March 22, 2021
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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer, Invasive Ductal||Device: Philips Sonalleve® MR-HIFU Breast Therapy System||Not Applicable|
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
|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: Correlation Between MRI and Histology. Single-Center, Single-Arm, Non-Randomized Trial|
|Actual Study Start Date :||January 13, 2020|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: MR-HIFU treatment
Patients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat& resect model
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.
- Accuracy of MRI as method for assessment of quantitative treatment success (correlation with results of the histopathological analysis performed as reference method) [ Time Frame: Day 14 ]Quantitative assessment: Correlation between MRI and histopathology results (volume of necrosis)
- Accuracy of MRI as method for assessment of qualitative treatment success (correlation with results of the histopathological analysis performed as reference method) [ Time Frame: Day 14 ]Qualitative assessment: spatial congruence of ablated tumor tissue and width of margin
- Assessment of treatment efficacy [ Time Frame: Day 14 ]
Effective treatment is defined as complete necrosis (100%) of targeted tumor including safety margin (>1mm) (histopathological analysis).
Safety margin: measurement of smallest margin on histology and measurement of smallest margin on MRI. Parameter: Percentage of necrosis including safety margin
- Incidence of adverse events [Safety and tolerability of the Treatment] [ Time Frame: Day 0, 3, 8 ]
Adverse events, general:
Patients will be asked to report information about adverse events at each time point of the study. Information about time of onset, duration, resolution, action to be taken assessment of intensity, relationship with study treatment will be collected.
Assessment of additional predefined safety parameters:
- Skin changes, assessment in physical examination: presence/absence of redness, burn
- Palpation breast: lump (mobility of lump related to skin: yes/no)
- Pain, reported by patient
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): NCT03560102
|Contact: Christoph A Binkert, MD||+41 52 266 firstname.lastname@example.org|
|Contact: Marlene Wegmann Oswald, PhD||+41 52 266 23 email@example.com|
|Principal Investigator:||Christoph A Binkert, MD||Kantonsspital Winterthur KSW|