Clinical trial NCT02610920: Sentinel Lymph Node Identification in the Axilla of Women With Breast Cancer Using Ultrasound and Iron Injection
Official title: Identification of Sentinel Lymph Nodes by Ultrasound Utilizing Iron Tracer Injection and Preoperative Biopsy in Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Breast Neoplasm
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Success rate of core needle biopsy of sentinel lymph node
timeFrame: At time of surgery, about 7 days after initial core needle biopsy
Secondary outcomes:
measure: Concordance rate of core needle biopsy pathology to sentinel lymph node biopsy pathology
timeFrame: At time of pathology reports, about 17 days after initial core needle biopsy
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: Bret Taback, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.