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| Name | Class |
|---|---|
| Endomagnetics Ltd. | INDUSTRY |
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The use of neoadjuvant chemotherapy in breast cancer is expanding in the recent decade. Patients with good response to neoadjuvant chemotherapy could benefit from de-escalation of breast and axilla operation. However, breast tumor and involved axillary lymph node should be marked before the commencement of chemotherapy. This could facilitate subsequent operative planning and intraoperative assessment of disease response. This study aims to evaluate the feasibility of magnetic marker localization for non-palpable breast cancer and targeted axillary dissection in patients with node-positive breast cancer following neoadjuvant therapy
Eligible patients will receive ultrasound guided placement of magnetic seeds (Magseed®) within the cortex of the sampled lymph node and epicenter of the breast tumor by radiologists before commencement of neoadjuvant treatment. Chemotherapeutic regimes will be determined by oncologists in charge. During the period of neoadjuvant treatment, patients will be followed up by oncologists and surgeons with clinical assessment of tumor response according to our usual practice. After completion of neoadjuvant chemotherapy, recruited patients will receive mammography and ultrasonography assessment before surgery. Breast conservative surgery with targeted axillary dissection will be offered when feasible. In patients not suitable for breast conservative surgery, mastectomy and targeted axillary dissection with or without immediate breast reconstruction will be offered.
Patient will receive localization of previously marked axillary lymph node and breast tumor and sentinel lymph node biopsy by magnetic means completely, i.e. by the use if magnetic seeds and superparamagnetic iron oxide injection. Radioisotope with Tc-99 is injected prior to operation as backup plan for sentinel lymph node biopsy. The clipped lymph node and sentinel lymph nodes are sent for frozen section analysis. If any of the lymph nodes is positive for malignancy, axillary dissection will be performed. Similarly, the breast tumor will be resected with guidance of magnetometer and specimen mammogram will confirm the presence of tumor and magnetic seeds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | Magnetic seed guided lumpectomy and targeted axillary dissection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic seed localization | Device | Magnetic seed guided localization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful localization of breast tumor and axillary lymph node | Successful surgical retrieval of magnetic seed marked breast tumor and axillary lymph node in intraoperative specimen mammogram (in percentage) | At the time of operation |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients that can avoid axillary lymph node dissection | Percentage of patients that can achieve nodal pathological complete response after neoadjuvant chemotherapy | up to 4 weeks |
| Percentage of successful magnetic seed guided lumpectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chi Mei Vivian Man, FCSHK, FRCSEd | Contact | 852-25898116 | vivian27@hku.hk | |
| Christine Chan, Miss | Contact | 852-2255 4773 | tcc0525@hku.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
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All patients received magnetic seeds guided localization of axillary lymph node and breast tumor and superparamagnetic iron oxide-guided sentinel lymph node biopsy
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Percentage of involved or close margins in lumpectomy specimen which require re-excision
| up to 4 weeks |
| Level of satisfaction from surgeons and radiologists | Level of satisfaction from surgeons and radiologists which will be determined by the satisfaction questionnaire | To be filled in by operating surgeons and radiologists at the time of operation or magnetic seeds placement |
| 5-year local regional recurrence rate | 5-year ipsilateral breast tumor recurrence rate and/or axillary recurrence rate | 5-year post-operatively |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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