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Breast Diseases

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Iron

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+® 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+® 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+® 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.

Sentinel node marking with Sienna+ retro-mamillary 1 day before surgery

Sienna+ retro

Sentinel node marking with Sienna+ peri-tumorally 1 day before surgery

Sienna+ peri

Sentinel node marking with Sienna+ retro-mamillary 4-6 days before surgery

Sienna+ retro 4-6

Sentinel node marking with Sienna+ peri-tumorally 4-6 days before surgery

Sienna+ peri 4-6

Sentinel node marking with Technetium 1 day before surgery

Technetium 1

Nik Hauser, PD Dr.

Cornelia Leo, PD Dr. med.

Patrizia Sager, Dr. med.

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:

* Sienna+® retro-mamillary 1 day before surgery: 10 patients
* Sienna+® peri-tumorally 1 day before surgery: 10 patients
* Sienna+® retro-mamillary 4-6 days before surgery: 10 patients
* Sienna+® peri-tumorally 4-6 days before surgery: 10 patients In each case, 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+® Injection Time Study 4 Arms

Sienna+® Injection Time Study: A Prospective Multicentre, Controlled Clinical Trial to Evaluate the Performance of Superparamagnetic Iron Oxide vs. Standard Technique as Tracer in Sentinel Node Biopsy

Proportion of successfully detected sentinel nodes (detection rate per patient) with both methods.

Number of detected versus excised sentinel lymph nodes with either method.

Number of histologically confirmed malignant sentinel lymph nodes detected with either method.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sienna+® Injection Time Study 4 Arms	NCT02612870	Breast Neoplasm...	Sienna+ retro Sienna+ peri Sienna+ retro 4... Sienna+ peri 4-... Technetium 1	18 Years - 85 Years	Kantonsspital Baden
Sienna+® Injection Time Study 4 Arms	NCT02612870	Breast Neoplasm...	Sienna+ retro Sienna+ peri Sienna+ retro 4... Sienna+ peri 4-... Technetium 1	18 Years - 85 Years	Kantonsspital Baden

Spots Global Cancer Trial Database for technetium 1

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