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

NCT ID: NCT02610920

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-01-31

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Iron-tracer Injection and Biopsy

Single injection of 30mg of iron sucrose followed by axillary ultrasound-guided biopsy of lymph node within 2 hours.

Group Type: EXPERIMENTAL

Iron-tracer guided axillary ultrasound and biopsy

Intervention Type: PROCEDURE

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).

Iron tracer

Intervention Type: DRUG

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.

Interventions

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).

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Other Intervention Names

Venofer; 75010550

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bret Taback, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

References

Kusminsky RE, Witsberger T, Todd Kuenstner J, Willis Trammell S, Schlarb CA, Maxwell D, Richmond BK, Boland JP. Identification of the sentinel node by ultrasonography in patients with breast cancer. Ann Surg Oncol. 2014 Jun;21(6):1969-74. doi: 10.1245/s10434-014-3570-4. Epub 2014 Feb 25.

Reference Type: BACKGROUND

PMID: 24566860 (View on PubMed)

Bailie GR. Comparison of rates of reported adverse events associated with i.v. iron products in the United States. Am J Health Syst Pharm. 2012 Feb 15;69(4):310-20. doi: 10.2146/ajhp110262.

Reference Type: BACKGROUND

PMID: 22302256 (View on PubMed)

Other Identifiers

AAAP8967

Identifier Type: -

Identifier Source: org_study_id