Breast Cancer, Invasive Ductal
Conditions
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
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
Interventions
DEVICEPhilips 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.
Sponsors
Kantonsspital Winterthur KSW
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed Consent as documented by signature * World Health Organization (WHO) performance status≤ 2 * Body weight ≤ 80 kg * Biopsy proven invasive breast cancer with a size of ≤3.0cm (TNM classification: cT1-2 N0-2 MX ). * Histological type of tumor: invasive ductal carcinoma (IDC) * Patient is scheduled for surgical resection of tumor at study site * Tumor location within the reach of the HIFU transducers with the patient in prone position; distance from skin and pectoral muscle to the tumor ≥ 1.0 cm. * Target breast fits in the cup of the dedicated MR-HIFU breast system
Exclusion criteria
* neoadjuvant systemic therapy * prior radiotherapy in target breast * contraindications for MRI * contraindication for application of gadolinium-based contrast agent * contraindication for procedural sedation analgesia * macro-calcifications in or around the targeted tumor * scar tissue or surgical clips in the direct path of the ultrasound beams * Women who are pregnant or breast feeding, * Intention to become pregnant during the course of the study, * Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. * Known or suspected non-compliance, drug or alcohol abuse, * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * Participation in another study with investigational drug/device within the 30 days preceding and during the present study, * Previous enrolment into the current study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of MRI as Method for Assessment of Quantitative Treatment Success (Correlation With Results of the Histopathological Analysis Performed as Reference Method) | Day 14 | Quantitative assessment: Correlation between MRI and histopathology results (volume of necrosis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Treatment Efficacy | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events [Safety and Tolerability of the Treatment] | 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 |
Countries
Switzerland
Participant flow
Recruitment details
First patient enroled: 06JAN2020 Last patient completed: 05FEB2020
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | MR-HIFU Treatment | — |
|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 0 | — |
| Height | 163 cm STANDARD_DEVIATION 0 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Switzerland | 1 participants | — |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
| Weight | 65 kg STANDARD_DEVIATION 0 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
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)
Time frame: Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MR-HIFU Treatment | Accuracy of MRI as Method for Assessment of Quantitative Treatment Success (Correlation With Results of the Histopathological Analysis Performed as Reference Method) | 168 percentage of histopathological result | Standard Deviation 0 |
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
Time frame: Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MR-HIFU Treatment | Assessment of Treatment Efficacy | 3.9 percentage of necrosis of targeted tumor | Standard Deviation 0 |
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 * Palpation breast: lump (mobility of lump related to skin: yes/no) * Pain, reported by patient
Time frame: Day 0, 3, 8
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MR-HIFU Treatment | Incidence of Adverse Events [Safety and Tolerability of the Treatment] | 0 Participants |