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Selective Image Guided Resection of Axillary Lymph Nodes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01880645
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Fine Needle Aspiration (FNA) Procedure: Ultrasound Procedure: Breast Surgery + Lymph Node Removal Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Feasibility of Selective Image Guided Resection of Cytologically Documented Axillary Lymph Node Metastases
Study Start Date : March 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Ultrasound + Breast Surgery + Lymph Node Removal
Patient receives an ultrasound of lymph nodes at diagnosis and on the day of surgery. Marker clip(s) placed using a needle in the abnormal lymph node(s). If patient received chemotherapy before surgery, fine needle aspiration (FNA) performed of any abnormal lymph nodes either right before or during standard breast and underarm surgery. To perform FNA, area is numbed with anesthetic and a needle is inserted into the affected area so that cells can be collected. Standard breast and underarm surgery (underarm lymph node removal and either a partial mastectomy or total mastectomy with or without reconstruction) performed.
Procedure: Fine Needle Aspiration (FNA)
If patient received chemotherapy before surgery, fine needle aspiration (FNA) performed of any abnormal lymph nodes either right before or during standard breast and underarm surgery. To perform FNA, area is numbed with anesthetic and a needle is inserted into the affected area so that cells can be collected.

Procedure: Ultrasound
Patient receives an ultrasound of lymph nodes at diagnosis and on the day of surgery. Marker clip(s) placed using a needle in the abnormal lymph node(s).

Procedure: Breast Surgery + Lymph Node Removal
Patient receives standard breast and underarm surgery (underarm lymph node removal and either a partial mastectomy or total mastectomy with or without reconstruction).




Primary Outcome Measures :
  1. Verification of Axillary Node Metastases Using Ultrasound Imaging Before and After Guided Excision [ Time Frame: 1 day ]
    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.


Secondary Outcome Measures :
  1. Absence of Residual Metastases [ Time Frame: 1 day ]
    Secondary objective defined as determination of whether the excised node contains metastases or not (defined as a lymph node with a metastasis greater than 0.2 mm in greatest dimension identified by H&E staining) and recording the presence or absence of residual metastases by repeat fine needle aspiration (FNA) at the time of surgery.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880645


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Henry Kuerer, MD,PHD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01880645    
Other Study ID Numbers: 2012-0163
NCI-2014-02440 ( Registry Identifier: NCI CTRP )
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015
Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Invasive breast cancer
Axillary lymph node metastases
Ultrasound
Fine needle aspiration
FNA
Lymph node surgery
Partial mastectomy
Total mastectomy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases