Thoracoscopic Internal Mammary Sentinel Node Biopsy
18 Years
N/A
Both
Breast Cancer
Trial Information
Thoracoscopic Internal Mammary Sentinel Node Biopsy
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Eli Avisar, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Miami Sylvester Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
EPROST-20040015
NCT ID:
NCT00450723
Start Date:
May 2004
Completion Date:
March 2011
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- male breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |
