Injection Methods in Finding the Sentinel Lymph Node During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Invasive Breast Cancer
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.
Drug: Isosulfan Blue
Radiation: Technetium Tc 99m sulfur colloid
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Preliminary Study To Explore Subareolar Injection As The Site For Lymphatic Mapping And Sentinel Lymph Node Biopsy In Patients With Breast Cancer|
- Lymphatic drainage patterns as determined by peritumoral and subareolar injections [ Time Frame: 12 months to collect data ] [ Designated as safety issue: No ]Evaluate outcome descriptively.
- Identification rate of sentinel nodes and negative predictive value associated with subareolar injection [ Time Frame: 12 months to collecte data ] [ Designated as safety issue: No ]Evaluate outcome descriptively.
|Study Start Date:||June 2005|
|Study Completion Date:||April 2008|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
Experimental: Injection Methods
One injection site with radioactive tracer intraparenchymal/peritumoral (around the tumor), and other subareolar (around the nipple)
Drug: Isosulfan Blue
At time of surgery, breast injected with 3-5 cc of isosulfan blue in subareolar or peritumoral position.
Other Name: lymphazurinProcedure: Lymphangiography
2 lymphoscintigraphy images performed following peritumoral and subareolar injection of breastRadiation: Technetium Tc 99m sulfur colloid
At least 2 days before scheduled surgery, receive technetium Tc 99m sulfur colloid by peritumoral injection; and again the day before surgery by subareolar injection.
At the time of surgery, patients receive isosulfan blue by subareolar injection.
- Compare subareolar injection with peritumoral injection in identifying the sentinel node during breast lymphatic mapping in patients with invasive breast cancer.
- Compare the lymphatic drainage patterns using lymphoscintigraphy of the breast with subareolar injection vs peritumoral injection.
OUTLINE: At least 2 days before scheduled surgery, patients receive technetium Tc 99m sulfur colloid by peritumoral injection followed by lymphoscintigraphy. Images are obtained at 30 minutes and after 2 and 3 hours, provided no drainage is noted. Patients then receive technetium Tc 99m sulfur colloid by subareolar injection followed by another lymphoscintigraphy.
At the time of surgery, patients receive isosulfan blue by subareolar injection. A handheld gamma probe is used to locate the sentinel node. If the sentinel node is identified, it is excised and the scheduled breast surgery is performed. If the sentinel node cannot be identified, patients undergo the scheduled breast surgery.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 12.5 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438477
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Gildy V. Babiera, MD||M.D. Anderson Cancer Center|
|Study Chair:||Ebrahim Delpassand, MD||M.D. Anderson Cancer Center|