Clinical trial · Interventional

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

Identification of Sentinel Lymph Nodes by Ultrasound Utilizing Iron Tracer Injection and Preoperative Biopsy in Women With Breast Cancer

NCT02610920CI-TRIAL-00037788withdrawnEarly Phase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Unable to enroll subjects

Summary

Brief summary (as posted)

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

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Neoplasm	Breast Neoplasm	ONTOLOGY_EXACT	0.98
Carcinoma, Ductal, Breast	Breast Ductal Carcinoma	ALIAS	0.90
Carcinoma, Intraductal, Noninfiltrating	Carcinoma	ONTOLOGY_EXACT	0.85

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Iron tracer	Drug	—	UNRESOLVED
Iron-tracer guided axillary ultrasound and biopsy	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Iron-tracer Injection and Biopsy
description
Single injection of 30mg of iron sucrose followed by axillary ultrasound-guided biopsy of lymph node within 2 hours.
interventionNames
1. Procedure: Iron-tracer guided axillary ultrasound and biopsy
2. Drug: Iron tracer

Primary outcomes (1)

measure
Success rate of core needle biopsy of sentinel lymph node
timeFrame
At time of surgery, about 7 days after initial core needle biopsy
description
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).

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (2)

BACKGROUNDKusminsky 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
BACKGROUNDBailie 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