Status:
COMPLETED
Injection Methods in Finding the Sentinel Lymph Node During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Invasive Breast Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
Phase:
NA
Brief Summary
RATIONALE: Diagnostic procedures, such as lymphoscintigraphy using an injection under the nipple or near the tumor, may help doctors find out how far the disease has spread. PURPOSE: This clinical tr...
Detailed Description
OBJECTIVES: * Compare subareolar injection with peritumoral injection in identifying the sentinel node during breast lymphatic mapping in patients with invasive breast cancer. * Compare the lymphatic...
Eligibility Criteria
Inclusion
- Patients must have either pathologic, radiologic or clinical evidence of breast cancer with invasion, suspicious for invasion or microinvasion.
- Patients who are candidates for a total mastectomy or segmental mastectomy or axillary dissection.
- Patients who have undergone neoadjuvant chemotherapy who have an FNA confirmed lymph node positive for metastatic disease prior to induction chemotherapy and are then found to have grossly palpable disease but are ultrasound node negative at time of study entry.
- Patients must sign an informed consent and be registered before the procedure is performed.
Exclusion
- A pregnancy test will be required preoperatively in women of childbearing potential and patients who are pregnant will be excluded from this study.
- Patients who have undergone neoadjuvant chemotherapy who have an FNA confirmed lymph node metastatic disease prior to induction chemotherapy and are then found to have grossly suspicious palpable disease and are ultrasound node positive at the time of study entry.
- Patients with known allergy to isosulfan blue dye or any related compounds.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00438477
Start Date
June 1 2005
End Date
April 1 2008
Last Update
July 30 2012
Active Locations (1)
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1
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009