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

NCT02046057 | Completed

• 1 other identifier: 5140020
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Sentinel Lymph Node; Ultrasound Guided Needle Core Biopsy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PNB of SLN

EXPERIMENTAL

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

Procedure: PNB of SLN

Interventions

PNB of SLN PROCEDURE

Percutaneous biopsy of sentinel node

PNB of SLN

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92350, United States

Location

Related Publications (1)

• 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.

  PMID: 27334213 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sharon S Lum, MD,FACS

  Loma Linda University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 27, 2014
• Study Start: February 12, 2014
• Primary Completion: August 13, 2024
• Study Completion: August 13, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)