Sentinel Lymph Node Biopsy With Superparamagnetic Iron Oxide for Breast

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02249208
Study type	Interventional
Source	Hospital Universitari Vall d'Hebron Research Institute
Contact	Isabel T Rubio, MD. PhD.
Email	irubio@vhio.net
Status	Recruiting
Phase	Phase 3
Start date	April 2014
Completion date	June 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Sentinel Lymph Node Biopsy With Superparamagnetic Iron Oxide for Breast Cancer Patients After Neoadjuvant Treatment. — SENTINAC-01

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms