NCT02249208

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 30, 2014

Status Verified

September 1, 2014

Enrollment Period

2.2 years

First QC Date

September 18, 2014

Last Update Submit

September 29, 2014

Conditions

Breast Cancer

Keywords

Breast CancerSentinel Lymph NodeNeoadjuvant ChemotherapyClinically Node-Positive with biopsy-proven cN1False-negative Rate

Outcome Measures

Primary Outcomes (1)

  • False Negative Rate

    The proportion of number of patients with a negative SLN biopsy with the number of patients with axillary lymph node metastases.

    3 months

Secondary Outcomes (1)

  • Detection Rate

    3 months

Study Arms (3)

Tc+blue dye

ACTIVE COMPARATOR

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+blue dye

Tc+SPIO

EXPERIMENTAL

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: Tc+SPIO

SPIO alone

EXPERIMENTAL

Sentinel Lymph Node (SLN) identification and resection using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery.

Device: SPIO alone

Interventions

Tc+blue dyeDEVICE

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

Tc+blue dye
Tc+SPIODEVICE

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

Tc+SPIO
SPIO aloneDEVICE

Sentinel Lymph Node (SLN) identification and resection using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery

SPIO alone

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven primary invasive breast cancer with clinical stage T1 through T3, N1 through N2, M0 according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, seventh edition
  • Completed or were planning to undergo neoadjuvant chemotherapy
  • Prechemotherapy axillary nodal disease confirmed by fine-needle aspiration or core-needle biopsy
  • The axilla is clinically and radiologically (by ultrasound) negative (ycN0) postchemotherapy and before surgery
  • Removal of at least two SLNs
  • Signed informed consent from each patient before study entry

You may not qualify if:

  • T4 tumors, cN3 or cM1
  • The axilla is clinically and radiologically (by ultrasound) positive (ycN1) postchemotherapy
  • Intolerance or hypersensitivity to the compounds or iron dextran or superparamagnetic iron oxide or to vital blue dye or radioactive product.
  • Chronic iron overload
  • Pacemaker or other metallic implantable device in the chest wall
  • Failure to submit to medical study for geographical, social or psychological
  • Patient deprived of liberty or under guardianship
  • Pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Vall D Hebron.

Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Isabel T Rubio, MD. PhD.

    Hospital Universitario Vall D Hebron. Universidad Autónoma de Barcelona.

    STUDY DIRECTOR

Central Study Contacts

Isabel T Rubio, MD. PhD.

CONTACT

irubio@vhio.net

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2014

First Posted

September 25, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 30, 2014

Record last verified: 2014-09

Locations

ES(1)