Clinical trial NCT02046057: Evaluation of Needle Core Biopsy of Axillary Sentinel Lymph Node in Breast Cancer
Official title: Evaluation of Needle Core Biopsy of Axillary Sentinel Lymph Node in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Sentinel Lymph Node
Ultrasound Guided Needle Core Biopsy
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Accuracy of axillary ultrasound guided percutaneous needle biopsy of sentinel node
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University Medical Center
name: Sharon S Lum, MD,FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.