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| Name | Class |
|---|---|
| Insel Gruppe AG, University Hospital Bern | OTHER |
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Patients with breast cancer normally undergo a labelling with radioactive tracer typically 1 day before surgery, which enables the surgeon to localize the sentinel lymph node during surgery. This pilot study uses the magnetic Sentimag technique to mark the lymph nodes either 1 or 4-6 days before surgery to investigate the concordance with the standard technique.
Sienna+® is injected either 1 day or 4-6 days before surgery, either retro-mamillary or peri-tumorally:
The Sentimag device is used during surgery to detect the lymph nodes in parallel to the standard technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sienna+ retro and Technetium 1 | Active Comparator | Sienna+® is administered retro-mamillary 1 day before surgery for sentinel node marking. Technetium as standard technique is employed according to the gold standard protocol one day before surgery. The Sentimag device is used during surgery to detect the lymph nodes in parallel to the standard technique. |
|
| Sienna+ peri and Technetium 1 | Active Comparator | Sienna+® is administered peri-tumorally 1 day before surgery for sentinel node marking. Technetium as standard technique is employed according to the gold standard protocol one day before surgery. The Sentimag device is used during surgery to detect the lymph nodes in parallel to the standard technique. |
|
| Sienna+ retro 4-6 and Technetium 1 | Active Comparator | Sienna+® is administered retro-mamillary 4-6 days before surgery for sentinel node marking. Technetium as standard technique is employed according to the gold standard protocol one day before surgery. The Sentimag device is used during surgery to detect the lymph nodes in parallel to the standard technique. |
|
| Sienna+ peri 4-6 and Technetium 1 | Active Comparator | Sienna+® is administered peri-tumorally 4-6 days before surgery for sentinel node marking. Technetium as standard technique is employed according to the gold standard protocol one day before surgery. The Sentimag device is used during surgery to detect the lymph nodes in parallel to the standard technique. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sienna+ retro | Device | Sentinel node marking with Sienna+ retro-mamillary 1 day before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate per Patient | Proportion of successfully detected sentinel nodes (detection rate per patient) with both methods. | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of lymph nodes excised | Number of excised sentinel lymph nodes | During surgery |
| Nodal detection rate | Number of detected versus excised sentinel lymph nodes with either method. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nik Hauser, PD Dr. | Contact | +41 56 486 36 36 | brustzentrum@ksb.ch | |
| Cornelia Leo, PD Dr. med. | Contact | +41 56 486 36 36 | brustzentrum@ksb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Nik Hauser, PD Dr. | Kantonsspital Baden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Baden | Baden | 5404 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24484967 | Result | Thill M, Kurylcio A, Welter R, van Haasteren V, Grosse B, Berclaz G, Polkowski W, Hauser N. The Central-European SentiMag study: sentinel lymph node biopsy with superparamagnetic iron oxide (SPIO) vs. radioisotope. Breast. 2014 Apr;23(2):175-9. doi: 10.1016/j.breast.2014.01.004. Epub 2014 Jan 29. | |
| 24322530 | Result |
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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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|
| Sienna+ peri | Device | Sentinel node marking with Sienna+ peri-tumorally 1 day before surgery |
|
| Sienna+ retro 4-6 | Device | Sentinel node marking with Sienna+ retro-mamillary 4-6 days before surgery |
|
| Sienna+ peri 4-6 | Device | Sentinel node marking with Sienna+ peri-tumorally 4-6 days before surgery |
|
| Technetium 1 | Device | Sentinel node marking with Technetium 1 day before surgery |
|
| During surgery |
| Malignancy rate | Number of histologically confirmed malignant sentinel lymph nodes detected with either method. | 1-2 days post surgery |
| Inselspital Bern, Universitätsklinik für Frauen. | Bern | 3010 | Switzerland |
|
| Douek M, Klaase J, Monypenny I, Kothari A, Zechmeister K, Brown D, Wyld L, Drew P, Garmo H, Agbaje O, Pankhurst Q, Anninga B, Grootendorst M, Ten Haken B, Hall-Craggs MA, Purushotham A, Pinder S; SentiMAG Trialists Group. Sentinel node biopsy using a magnetic tracer versus standard technique: the SentiMAG Multicentre Trial. Ann Surg Oncol. 2014 Apr;21(4):1237-45. doi: 10.1245/s10434-013-3379-6. Epub 2013 Dec 10. |
| 26365441 | Result | Ghilli M, Carretta E, Di Filippo F, Battaglia C, Fustaino L, Galanou I, Di Filippo S, Rucci P, Fantini MP, Roncella M. The superparamagnetic iron oxide tracer: a valid alternative in sentinel node biopsy for breast cancer treatment. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12385. Epub 2015 Sep 14. |
| 25466980 | Result | Rubio IT, Diaz-Botero S, Esgueva A, Rodriguez R, Cortadellas T, Cordoba O, Espinosa-Bravo M. The superparamagnetic iron oxide is equivalent to the Tc99 radiotracer method for identifying the sentinel lymph node in breast cancer. Eur J Surg Oncol. 2015 Jan;41(1):46-51. doi: 10.1016/j.ejso.2014.11.006. Epub 2014 Nov 15. |
| D017437 |
| Skin and Connective Tissue Diseases |