Spots Global Cancer Trial Database for Sienna+® Injection Time Study 4 Arms

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Trial Identification

Brief Title: Sienna+® Injection Time Study 4 Arms

Official Title: 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

Study ID: NCT02612870

Conditions

Breast Neoplasms

Interventions

Study Description

Brief Summary: 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.

Detailed Description: 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.