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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: PNB of SLN

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PNB of SLN; Percutaneous core biopsy of sentinel node prior to standard sentinel node dissection	Procedure: PNB of SLN; Percutaneous biopsy of sentinel node

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Sharon S Lum, MD,FACS, Loma Linda University Medical Center

Publications and helpful links

General Publications

• Pairawan SS, Cora C, Olaya W, Deisch J, Garberoglio R, Solomon N, Senthil M, Garberoglio C, Lum SS. Percutaneous Sentinel Node Biopsy in Breast Cancer: Results of a Phase 1 Study. Ann Surg Oncol. 2016 Oct;23(10):3330-6. doi: 10.1245/s10434-016-5320-2. Epub 2016 Jun 22.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2014
• Primary Completion (Actual): August 13, 2024
• Study Completion (Actual): August 13, 2024

Study Registration Dates

• First Submitted: January 22, 2014
• First Submitted That Met QC Criteria: January 23, 2014
• First Posted (Estimated): January 27, 2014

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Sentinel Lymph Node; Ultrasound Guided Needle Core Biopsy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 5140020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No