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The feasibility of the use of magnetic clips for tumour localisation before preoperative chemotherapy in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection and in combination with a magnetic clip in the index lymph node metastasis is studied.
The overall aim is to demonstrate that the use of magnetic clips for tumour localisation before preoperative chemotherapy is feasible at breast cancer surgery and histopathological evaluation in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection, and in combination with a magnetic clip in the index lymph node metastasis if targeted axillary surgery is planned.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumour localisation with Magseed | Experimental | Before preoperative chemotherapy a Magseed is inserted in the breast tumour |
|
| Metallic marker + guide wire | Active Comparator | Before preoperative chemotherapy an ordinary metallic clip is inserted in the breast tumour. Before surgery a guide wire is inserted to localise the clip. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magseed | Device | Tumour localizer |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Specimen volume | The surgical specimen is weighed after removal. | Perioperatively |
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Inclusion Criteria:
Exclusion Criteria:
Breast conserving surgery
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fredrik Warnberg, prof | Contact | +46706146251 | fredrik.warnberg@vgregion.se | |
| Kian Chin, MD | Contact | +46702316011 | kian.chin@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Roger Olofsson Bagge, prof | Sahlgrenska Academy at Gothenburg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska Academy at Gothenburg University | Recruiting | Gothenburg | Göteborg | 41345 | Sweden |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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One part feasibility and one part randomised.
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| Metallic clip and guide wire |
| Device |
Tumour localizers |
|
| D017437 |
| Skin and Connective Tissue Diseases |