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Sentinel Lymph Node Identification in the Axilla of Women With Breast Cancer Using Ultrasound and Iron Injection

NCT02610920 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2019-03-26

No results posted yet for this study

Summary

This study evaluates a new method of testing the lymph nodes in the armpit of patients with breast cancer for tumor involvement. All participants involved in this study will undergo an injection of a small amount of iron dissolved in liquid followed by an ultrasound of the axilla that will make previously invisible lymph nodes visible, allowing them to be sampled in an outpatient setting.

Conditions

  • Breast Neoplasm
  • Carcinoma, Ductal, Breast
  • Carcinoma, Intraductal, Noninfiltrating

Interventions

PROCEDURE

Iron-tracer guided axillary ultrasound and biopsy

After ultrasound identifying sentinel lymph nodes, no more than two nodes will be core-needle biopsied and sent to pathology department for analysis of cancer involvement. The biopsied node(s) will be marked for later identification for the surgeons during the regularly scheduled intraoperative sentinel lymph node biopsy (standard of care).

DRUG

Iron tracer

All participants will receive a 30mg injection of subcutaneous iron sucrose into the breast followed by an axillary ultrasound looking for lymph nodes with enhanced reflexivity.

Sponsors & Collaborators

Principal Investigators

  • Bret Taback, MD · Columbia University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-06-30
Completion
2018-01-31
FDA Drug
Yes

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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 NCT02610920 on ClinicalTrials.gov