Selective Image Guided Resection of Axillary Lymph Nodes

NCT01880645 | Completed

• 2 other identifiers: 2012-0163NCI-2014-02440
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 day

Secondary Outcomes (1)

• Absence of Residual Metastases

  1 day

Study Arms (1)

Ultrasound + Breast Surgery + Lymph Node Removal

OTHER

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); Procedure: Ultrasound; Procedure: Breast Surgery + Lymph Node Removal

Interventions

Fine Needle Aspiration (FNA) PROCEDURE

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.

Ultrasound + Breast Surgery + Lymph Node Removal

Ultrasound PROCEDURE

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).

Ultrasound + Breast Surgery + Lymph Node Removal

Breast Surgery + Lymph Node Removal PROCEDURE

Patient receives standard breast and underarm surgery (underarm lymph node removal and either a partial mastectomy or total mastectomy with or without reconstruction).

Ultrasound + Breast Surgery + Lymph Node Removal

Eligibility Criteria

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

You may qualify if:

• Greater than or equal to 18 years old.
• Histologic diagnosis of invasive breast cancer, clinical stage T0-3 N1 (maximum one or two abnormal axillary nodes on ultrasound exam) M0.
• FNA biopsy (or core needle biopsy) of an axillary node documenting nodal disease at time of diagnosis and prior to preoperative chemotherapy or surgery.
• Marker clip placed in the one or two abnormal axillary nodes identified at ultrasound.

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy, Fine-Needle; High-Energy Shock Waves; Lymph Node Excision

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Henry Kuerer, MD,PHD

  M.D. Anderson Cancer 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: June 12, 2013
• First Posted: June 19, 2013
• Study Start: March 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

US (1)