Injection Methods in Finding the Sentinel Lymph Node During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Invasive Breast Cancer

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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 trial is studying two different injection methods to compare how well they find the sentinel lymph node during lymphatic mapping and sentinel lymph node biopsy in patients with invasive breast cancer.

Key facts

Study ID

NCT00438477

Run by

M.D. Anderson Cancer Center

People needed

74

Starts

2005-06-01

Expected to finish

2008-04-01

Last updated by the study team

2012-07-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• M. D. Anderson Cancer Center at University of Texas — Houston, Texas, United States

Full record on ClinicalTrials.gov

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