Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer

December 14, 2016 updated by: University of Miami

Thoracoscopic Internal Mammary Sentinel Node Biopsy

RATIONALE: Diagnostic procedures, such as thoracoscopic sentinel lymph node biopsy, may help find breast cancer that has spread to lymph nodes between the breasts. It may also help doctors plan the best treatment.

PURPOSE: This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy finds sentinel lymph nodes that are located between the breasts in patients with stage I or stage II breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the occurrence rate of internal mammary sentinel lymph nodes in patients with medially or centrally located stage I or II breast cancer.
  • Determine the safety, feasibility, and success rate of thorascopic internal mammary sentinel lymph node biopsy in these patients.
  • Determine the rate of metastatic disease in internal mammary sentinel lymph nodes obtained thoracoscopically in these patients.

OUTLINE: Patients undergo standard axillary sentinel lymph node dissection during surgery (i.e., lumpectomy or mastectomy). Patients receive a radioactive tracer (i.e., technetium Tc 99m sulfur colloid) and isosulfan blue by peritumoral injection for identification of the axillary and internal mammary sentinel lymph nodes (IMSLN). Identified axillary sentinel lymph nodes are dissected. Identified IMSLNs are removed through the lumpectomy/mastectomy incision, if accessible. If they are not accessible, patients undergo thorascopic IMSLN biopsy to remove the nodes.

All removed sentinel lymph nodes (axillary or internal mammary) are examined for gross and microscopic carcinoma for future therapy planning.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center - Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer

    • Stage I or II disease (T1-T2, N0, M0/MX disease)

      • No chest wall invasion by tumor (T3 disease)
  • Medially or centrally located lesion

  • No multicentric disease

    • Multifocal disease allowed
  • No clinically positive axillary nodes
  • No enlarged internal mammary nodes by CT scan
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Male or female
  • Menopausal status not specified
  • American Society of Anesthesiologists (ASA) physical status classification 1-2
  • Not pregnant or nursing
  • Negative pregnancy test
  • No other concurrent known, invasive malignancy
  • No known chronic pulmonary disease
  • No known allergy to methylene blue or isosulfan blue

PRIOR CONCURRENT THERAPY:

  • No prior thoracic or cardiac surgery

  • No prior ipsilateral chest tube placement

    • Contralateral chest tube placement allowed
  • No prior neoadjuvant chemotherapy
  • No prior radiotherapy to the mediastinum

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sentinel Lymph Node Biopsy
Drug: Isosulfan blue
Administered pre-surgery; injection of 2 cc of Isosulfan Blue in four equal aliquots of 0.5 cc as routinely done for the axillary sentinel node procedure.
Other Names:
  • Lymphazurin
Procedure: Axillary Lymph Node Dissection
Axillary Lymph Node Dissection
Procedure: Surgery
The surgery will be performed under general anesthesia with a single lumen endo-tracheal tube. The patient will be laid in a semi decubitus position on the opposite side with the ipsilateral arm bent over the head and attached to an arm rest.
Procedure: Sentinel Lymph Node Biopsy
Sentinel Lymph Node Biopsy
Procedure: Thoracoscopic Surgery
Performed only if internal mammary sentinel node cannot be retrieved via same incision of lumpectomy/mastectomy.
Radiation: Technetium Tc 99m Sulfur Colloid
Two to three hours prior to surgery, a peritumoral injection of filtered Technetium Sulfur Colloid will be performed in four 0.25 mci/2cc aliquots

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy
Time Frame: 5 years
5 years
Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes
Time Frame: 5 years
5 years
Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Study Chair: Eli Avisar, MD, University of Miami Sylvester Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 20, 2007

First Submitted That Met QC Criteria

March 20, 2007

First Posted (Estimate)

March 22, 2007

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

December 14, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20040015
  • SCCC-2003161 (Other Identifier: University of Miami Sylvester Comprehensive Cancer Center)
  • WIRB-20050911 (Other Identifier: Western Institutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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