MedTrace Logo

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

NCT02249208 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2014-09-30

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Sysmex España S.L.

    collaborator INDUSTRY

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Isabel T Rubio, MD. PhD. · Hospital Universitario Vall D Hebron. Universidad Autónoma de Barcelona.

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02249208 on ClinicalTrials.gov