NCT02612870

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Kantonsspital Baden · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DEVICE	Sienna+ retro	Sentinel node marking with Sienna+ retro-mamillary 1 day before surgery
DEVICE	Sienna+ peri	Sentinel node marking with Sienna+ peri-tumorally 1 day before surgery
DEVICE	Sienna+ retro 4-6	Sentinel node marking with Sienna+ retro-mamillary 4-6 days before surgery
DEVICE	Sienna+ peri 4-6	Sentinel node marking with Sienna+ peri-tumorally 4-6 days before surgery
DEVICE	Technetium 1	Sentinel node marking with Technetium 1 day before surgery

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-11-24
• Last updated: 2015-11-24

Locations

2 sites across 1 country: Switzerland