An interventional study of PNB of SLN in Breast Cancer, sponsored by Loma Linda University. Completed at 1 site in United States. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Loma Linda University · Not applicable, Interventional, and Diagnostic
The purpose of the study is to determine if it is possible to identify and perform a needle biopsy of the sentinel lymph node. The investigators hope to identify breast cancer cells in the lymph nodes under the arm without making an operation necessary.
The rationale for this study is that for patients without enlarged lymph nodes under the arm, sentinel lymph node biopsy is the standard way of determining if breast cancer has spread to the lymph nodes under the arm. While the complications from a sentinel lymph node dissection are less than that of a complete axillary lymph node dissection, sentinel lymph node dissection still carries small risks of arm swelling, decreased movement, fluid collections, nerve injury, and pain. Furthermore, the majority of sentinel lymph nodes do not contain cancer. The investigators hope to develop a method to find cancer in the axillary lymph nodes and avoid the complications of an operation.
In patients already scheduled to undergo sentinel lymph node dissection in the operating room, the investigators will first perform an axillary ultrasound guided core needle biopsy percutaneously. Patients will have already undergone prior injection of radioisotope and blue dye and as a standard procedure or the sentinel lymph node dissection. After induction of anesthesia, the investigators will identify the location of the sentinel node with a gamma probe to identify the "pre-incision hot spot." Axillary ultrasound will then be used to identify the location of the lymph node and a percutaneous core needle biopsy of the targeted lymph node will be performed. The core biopsy specimen will be evaluated for the presence of blue staining and radioisotope uptake intraoperatively. The core biopsy specimen will then will be sent for pathologic analysis. The percutaneous biopsy should take about 10 minutes of additional operating room time. The operation will then proceed as planned with dissection and removal of the remaining sentinel node(s). Core samples and sentinel lymph nodes will be evaluated in a similar fashion per existing sentinel node protocol.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 25 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
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Exclusion Criteria:
Percutaneous core biopsy of sentinel node prior to standard sentinel node dissection
Procedure: PNB of SLN
Percutaneous biopsy of sentinel node
Accuracy of axillary ultrasound guided percutaneous needle biopsy of sentinel node
False positive and false negative rates of ultrasound guided needle biopsy of sentinel node will be determined by comparison of results with gold standard of open surgical sentinel node dissection.
Time frame: 2 years
Plan to share: No
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Loma Linda University