NCT02249208

Sentinel Lymph Node Biopsy With Superparamagnetic Iron Oxide for Breast Cancer Patients After Neoadjuvant Treatment.

Sentinel Lymph Node Biopsy With Superparamagnetic Iron Oxide vs. Standard Technique After Neoadjuvant Chemotherapy in Patients With Node-Positive Breast Cancer. A Randomized Controlled Trial.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the detection rate and the false negative rate of sentinel lymph node (SLN) by superparamagnetic iron oxide (SPIO) alone or in addition to radioisotope and compared to the standard method (blue and radioisotope) after neoadjuvant chemotherapy in patients with node-positive breast cancer converted to node negative after treatment by ultrasound. A randomized controlled trial.

Detailed description

Identification of Sentinel node: * Arm 1 (Tc+blue dye): Identification of SLN using the standard technique of sub-areolar injection of technetium-99m (Tc-99m) and vital blue dye before surgery. * Arm 2 (Tc+SPIO): Identification of SLN using standard isotope technique of sub-areolar injection of technetium-99m (Tc-99m) before surgery and the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery and detection with the SentiMag® probe. (Study) * Arm 3 (SPIO alone): Identification of SLN using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery and detection with the SentiMag® probe. (Study) Sentinel node's excision of radioactive and / or blue and / or magnetic (colored brown-brown), detection guided by hand probe gamma radiation, colorimetric and / or and SentiMag® paramagnetic probe. Lymph nodes that are radioactive, blue, magnetic or palpable are considered SLNs and are resected and submitted for pathological analysis. The protocol required that at least 2 SLNs to be resected. In all cases a completion axillary lymphadenectomy nodes dissection (ALND) will be performed after SLN biopsy. All SLNs will be excised and submitted before performing the ALND. Characterization of the nodal status of patients with the detection rate and the false negative rate of SLN for each arm.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Tc+blue dye	Sentinel Lymph Node (SLN) identification and resection using the standard technique of sub-areolar injection of technetium-99m (Tc-99m) and sub-areolar injection of vital blue dye before surgery
DEVICE	Tc+SPIO	Sentinel Lymph Node (SLN) identification and resection using isotope technique of sub-areolar injection of technetium-99m (Tc-99m) and the magnetic technique with the sub-areolar injection of SPIO (Sienna+®), before surgery
DEVICE	SPIO alone	Sentinel Lymph Node (SLN) identification and resection using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2014-09-25
• Last updated: 2014-09-30

Locations

1 site across 1 country: Spain