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

NCT ID: NCT02046057

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-12
• Study Completion Date: 2024-08-13

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PNB of SLN

Percutaneous core biopsy of sentinel node prior to standard sentinel node dissection

Group Type: EXPERIMENTAL

PNB of SLN

Intervention Type: PROCEDURE

Percutaneous biopsy of sentinel node

Interventions

PNB of SLN

Percutaneous biopsy of sentinel node

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon S Lum, MD,FACS

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Medical Center

Locations

Loma Linda University Medical Center

Loma Linda, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27334213 (View on PubMed)

Other Identifiers

5140020

Identifier Type: -

Identifier Source: org_study_id