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

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Columbia University

Status and phase

Withdrawn
Early Phase 1

Conditions

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

Treatments

Procedure: Iron-tracer guided axillary ultrasound and biopsy
Drug: Iron tracer

Study type

Interventional

Funder types

Other

Identifiers

NCT02610920
AAAP8967

Details and patient eligibility

About

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.

Full description

Lymph nodes are small collections of tissue all over the body that drain bodily fluid. These axillary lymph nodes are important in evaluating breast cancer since, if they are positive, it suggests that the cancer cells have spread outside of the breast. The current standard of care is for most breast cancer patients undergoing surgery to have a sentinel lymph node biopsy which is a procedure to take a sample of the lymph nodes in the armpit (also called the axilla) during their breast surgery. However this intraoperative biopsy comes with certain risks such as arm swelling or lymphedema, arm pain, arm numbness/tingling, and/or psychological distress from waiting for the results or the possibility of further interventions. In order to avoid this and have a result before surgery, this study will explore a nonsurgical method of sampling these lymph nodes. Normally suspicious lymph nodes are hard to find accurately by exam and ultrasound. A new method has been developed that involves injecting a small amount of iron dissolved in liquid into the breast that gets absorbed by the lymph nodes making them bright on ultrasound and possible to biopsy. This method has been shown to have results as accurate as standard sentinel lymph node biopsy by comparing them in the operating room. This study will now investigate performing these ultrasounds and biopsies in the office as well as compare these results to the results of the standard sentinel lymph node biopsy in the operating room. The results of this study could help future breast cancer patients to avoid invasive sampling and all of the accompanying risk as well as give patients and the care team an idea of the extent of disease sooner in order to guide management.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female patients at least 21 years old Patients with invasive ductal carcinoma staged T1 or T2 with estrogen receptor and progesterone receptor positive (ER+/PR+) who are scheduled for sentinel lymph node biopsy Patients with Ductal Carcinoma In Situ (DCIS) (high or low grade) who are scheduled for sentinel lymph node biopsy including: Patients having a mastectomy Patients with palpable DCIS Patients undergoing breast conservation with large (>5cm) area of DCIS Patients with signed consent to participate

Exclusion criteria

Preoperative palpable axillary lymphadenopathy Preoperative ultrasound demonstrating suspicious adenopathy Previous axillary dissection or previous lymph node biopsy Patients with Invasive Lobular Carcinoma Patients who are pregnant

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Iron-tracer Injection and Biopsy
Experimental group
Description:
Single injection of 30mg of iron sucrose followed by axillary ultrasound-guided biopsy of lymph node within 2 hours.
Treatment:
Drug: Iron tracer
Procedure: Iron-tracer guided axillary ultrasound and biopsy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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