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Completed

NCT Number: NCT00450723

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Breast Neoplasms, Male Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

isosulfan blue

Drug

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

Axillary Lymph Node Dissection

Procedure

Axillary Lymph Node Dissection

Surgery

Procedure

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.

Sentinel Lymph Node Biopsy

Procedure

Sentinel Lymph Node Biopsy

Thoracoscopic Surgery

Procedure

Performed only if internal mammary sentinel node cannot be retrieved via same incision of lumpectomy/mastectomy.

technetium Tc 99m sulfur colloid

Radiation

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

Primary outcomes

  1. Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy

    Time frame: 5 years

  2. Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes

    Time frame: 5 years

  3. Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Thoracoscopic Internal Mammary Sentinel Node Biopsy

Important dates

Study start
2004
Primary completion
2011
Study completion
2011
First posted
Mar 22, 2007
Registry last updated
Feb 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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