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

NCT02610920 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: AAAP8967
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Success rate of core needle biopsy of sentinel lymph node

  The participants will undergo an outpatient iron tracer-guided ultrasound and axillary lymph node core needle biopsy at "day zero" (purposely done no more than 7 days prior to scheduled breast surgery). The investigators would like to see if this biopsied node was in fact the sentinel lymph node. This will be determined by all of the patients also undergoing their previously scheduled intraoperative sentinel lymph node biopsy (standard of care) at about day 7. The success rate will measure what percentage of the preoperative lymph nodes biopsied with this novel technique were truly sentinel lymph node(s).

  At time of surgery, about 7 days after initial core needle biopsy

Secondary Outcomes (1)

• Concordance rate of core needle biopsy pathology to sentinel lymph node biopsy pathology

  At time of pathology reports, about 17 days after initial core needle biopsy

Study Arms (1)

Iron-tracer Injection and Biopsy

EXPERIMENTAL

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

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

Interventions

Iron-tracer guided axillary ultrasound and biopsy 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 Injection and Biopsy

Iron tracer 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.

Also known as: Venofer, 75010550

Iron-tracer Injection and Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Related Publications (2)

• 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.

  PMID: 24566860 BACKGROUND

• 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.

  PMID: 22302256 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Ductal, Breast; Carcinoma, Intraductal, Noninfiltrating

Interventions

Biopsy; Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ; Carcinoma in Situ

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Bret Taback, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2015
• First Posted: November 20, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: January 1, 2018
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share