An Early Phase 1 interventional study of Iron-tracer guided axillary ultrasound and biopsy and Iron tracer in Breast Neoplasm, Carcinoma, Ductal, Breast and Carcinoma, Intraductal, Noninfiltrating, sponsored by Columbia University. Withdrawn. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-26.
Sponsored by Columbia University · Early Phase 1, Interventional, and Diagnostic
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.
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.
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Exclusion Criteria:
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
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).
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
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).
Time frame: At time of surgery, about 7 days after initial core needle biopsy
Concordance rate of core needle biopsy pathology to sentinel lymph node biopsy pathology
The investigators will measure the concordance rate of the novel iron-tracer guided lymph node core needle biopsy pathology results (determining if cancer cells are present or not) compared to the operative sentinel lymph node pathology results. The novel technique core needle biopsy will occur on day zero. The surgery with concurrent sentinel lymph node biopsy will be on or before day 7, and both pathology reports should be back by day 17.
Time frame: At time of pathology reports, about 17 days after initial core needle biopsy
No study locations are listed for this record.
Plan to share: No
This study is withdrawn, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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