Selective Image Guided Resection of Axillary Lymph Nodes

Breast Cancer Clinical Trial

Official title: Feasibility of Selective Image Guided Resection of Cytologically Documented Axillary Lymph Node Metastases

Status Completed

Clinical Trial Summary

The goal of this clinical research study is to learn if it is feasible to use find (using ultrasound) and surgically remove cancer that has spread to the lymph nodes, during routine lymph node surgery.

In standard care, all affected lymph nodes are removed. In this study, however, the cancerous lymph nodes will be removed separately and then the rest of the lymph nodes under the arm will be removed after that.

Clinical Trial Description

Before surgery, patient may or may not receive the standard chemotherapy drug(s) that their doctor recommends. If patient's doctor suggests chemotherapy before surgery, they will be asked to sign a separate consent form that describes the chemotherapy and its risks.

On the day of surgery, patient will have an ultrasound of their lymph nodes. If patient has received chemotherapy before their surgery, they will have a fine needle aspiration (FNA) of any abnormal lymph nodes either right before or during their standard breast and underarm surgery. The abnormal lymph nodes will be marked for the surgeon to remove using standard techniques with either ultrasound, a mammogram, or 125I-seed placement. To perform an FNA, the area is numbed with anesthetic and a needle is inserted into the affected area so that cells can be collected. Ultrasound imaging is used to guide the needle into the area. The cells will be used for research to learn if the chemotherapy killed the abnormal lymph node cells.

Patient will have standard breast and underarm surgery (underarm lymph node removal and either a partial mastectomy or total mastectomy with or without reconstruction). Patient's doctor will discuss the surgery with patient in more detail and patient will be asked to sign a separate consent form.

During this surgery, the 1 or 2 abnormal underarm lymph nodes found by ultrasound will be removed and sent as separate samples before the rest of the underarm lymph nodes are removed.

Patient's study participation will be complete after surgery.

This is an investigational study. The surgery in this study is standard treatment. It is investigational to remove the abnormal lymph nodes before the rest of the underarm lymph nodes are removed. In this study, the exact same number of lymph nodes would be removed as is standard, but the surgery is being done in a 2-step process.

Up to 12 patients will take part in this study. All will be enrolled at MD Anderson. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer

• NCT number: NCT01880645
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Completion date: September 2015