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Completed

NCT Number: NCT02046057

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Medical Center

Loma Linda, California, 92350, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PNB of SLN

Procedure

Percutaneous biopsy of sentinel node

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Acronym: ENCASe

Important dates

Study start
2014
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2014
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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