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

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.

Inclusion Criteria:

• Subject has a diagnosis of primary breast cancer
• Subject has been scheduled for surgery with a sentinel lymph node biopsy procedure
• Subject is ≥18 years old at time of consent
• Subject has an ECOG performance status of Grade 0-2
• Subject has a clinical negative node status
• Subject is available for the follow-up

Exclusion Criteria:

• Subject is pregnant or lactating
• Subject has a radiological evidence of metastatic cancer
• Subject has had previous axilla surgery or reduction mammoplasty
• Subject has impaired lymphatic function
• Subject has had a preoperative radiation therapy
• Subject has iron overload disease or iron/dextran intolerance
• Subject has a pacemaker
• Subject is under guardianship