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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-MD-0021 | Other Identifier | Swissmedic |
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recruitment difficulties
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MR-HIFU treatment | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Philips Sonalleve® MR-HIFU Breast Therapy System | Device | The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of MRI as Method for Assessment of Quantitative Treatment Success (Correlation With Results of the Histopathological Analysis Performed as Reference Method) | Quantitative assessment: Correlation between MRI and histopathology results (volume of necrosis) | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Treatment Efficacy | 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 | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events [Safety and Tolerability of the Treatment] | 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
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph A Binkert, MD | Kantonsspital Winterthur KSW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Winterthur | Winterthur | CH-8401 | Switzerland |
Due to difficulties in recruitment only 2 patients were screened for inclusion and only 1 patient met inclusion criteria and was enrolled in the study.
First patient enroled: 06JAN2020 Last patient completed: 05FEB2020
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Accuracy of MRI as Method for Assessment of Quantitative Treatment Success (Correlation With Results of the Histopathological Analysis Performed as Reference Method) | Quantitative assessment: Correlation between MRI and histopathology results (volume of necrosis) | Posted | Mean | Standard Deviation | percentage of histopathological result | Day 14 |
|
Follow-up: Day 2, Day 8 (End of study)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christoph A Binkert (Sponsor-Investigator) | Kantonsspital Winterthur | +41 52 266 2602 | christoph.binkert@ksw.ch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2017 | Sep 23, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018270 | Carcinoma, Ductal, Breast |
| ID | Term |
|---|---|
| D044584 | Carcinoma, Ductal |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| Day 0, 3, 8 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Assessment of Treatment Efficacy | 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 | Posted | Mean | Standard Deviation | percentage of necrosis of targeted tumor | Day 14 |
|
|
|
| Other Pre-specified | Incidence of Adverse Events [Safety and Tolerability of the Treatment] | 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
| Posted | Count of Participants | Participants | Day 0, 3, 8 |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
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| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |