Evaluation of Needle Core Biopsy of Axillary Sentinel Lymph Node in Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: PNB of SLN

• Registration Number: NCT02046057
• Lead Sponsor: Loma Linda University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-23
• Study First Posted: 2014-01-27
• Study Start: 2014-02-12
• Primary Completion: 2024-08-13
• Study Completion: 2024-08-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• Breast cancer patients eligible for sentinel node dissection
• Invasive ductal or invasive lobular carcinoma
• Ductal carcinoma in situ undergoing total mastectomy
• Clinically node-negative
• 18-100 years

Exclusion Criteria

• Inflammatory breast cancer
• Pregnant or lactating
• Preoperative chemotherapy
• Prior axillary ultrasound guided core needle biopsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PNB of SLN	PNB of SLN	Percutaneous core biopsy of sentinel node prior to standard sentinel node dissection

Primary Outcome Measures

Name	Time	Method
Accuracy of axillary ultrasound guided percutaneous needle biopsy of sentinel node	2 years	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.

Trial Locations

Locations (1)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States