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

October 15, 2024 updated by: Loma Linda University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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