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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.


Inclusion Criteria:



1. Greater than or equal to 18 years old.

2. Histologic diagnosis of invasive breast cancer, clinical stage T0-3 N1 (maximum one
or two abnormal axillary nodes on ultrasound exam) M0.

3. FNA biopsy (or core needle biopsy) of an axillary node documenting nodal disease at
time of diagnosis and prior to preoperative chemotherapy or surgery.

4. Marker clip placed in the one or two abnormal axillary nodes identified at
ultrasound.

Exclusion Criteria:

1) Prior axillary lymph node surgery for pathological confirmation of axillary status.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Verification of Axillary Node Metastases Using Ultrasound Imaging Before and After Guided Excision

Outcome Description:

Patients required to have a minimum of at least two nodal ultrasounds: once at diagnosis and once prior to surgery. Marker clip placed in the one or two abnormal node(s) at diagnosis and on day of surgery. Nodes localized by ultrasound (or by mammographic or 125I-seed localization if not visualized well with ultrasound) for excision, and fine needle aspiration (FNA) repeated of previous abnormal nodes. Patients undergo standard breast and axillary surgery. During surgery the one or two abnormal axillary nodes identified by ultrasound are removed. The lymph nodes excised with the clip will be evaluated with specimen x-ray. If no marker clip is identified in the lymph node(s), the axillary contents will be x-rayed to document removal of the marker clip. Procedure considered a success if all marker clips are successfully identified in the preoperative ultrasound and documented in a lymph node via postoperative specimen x-ray of the excised material.

Outcome Time Frame:

1 day

Safety Issue:

No

Principal Investigator

Henry Kuerer, MD,PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2012-0163

NCT ID:

NCT01880645

Start Date:

March 2013

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Invasive breast cancer
  • Axillary lymph node metastases
  • Ultrasound
  • Fine needle aspiration
  • FNA
  • Lymph node surgery
  • Partial mastectomy
  • Total mastectomy
  • Breast Neoplasms

Name

Location
University of Texas MD Anderson Cancer Center Houston, Texas  77030