Injection Methods in Finding the Sentinel Lymph Node During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Invasive Breast Cancer
NCT ID: NCT00438477
Last Updated: 2012-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
74 participants
INTERVENTIONAL
2005-06-30
2008-04-30
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Injection Methods
One injection site with radioactive tracer intraparenchymal/peritumoral (around the tumor), and other subareolar (around the nipple)
Isosulfan Blue
At time of surgery, breast injected with 3-5 cc of isosulfan blue in subareolar or peritumoral position.
Lymphangiography
2 lymphoscintigraphy images performed following peritumoral and subareolar injection of breast
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.
Interventions
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Isosulfan Blue
At time of surgery, breast injected with 3-5 cc of isosulfan blue in subareolar or peritumoral position.
Lymphangiography
2 lymphoscintigraphy images performed following peritumoral and subareolar injection of breast
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients who are candidates for a total mastectomy or segmental mastectomy or axillary dissection.
3. 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.
4. Patients must sign an informed consent and be registered before the procedure is performed.
Exclusion Criteria
2. 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.
3. Patients with known allergy to isosulfan blue dye or any related compounds.
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Gildy V. Babiera, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Ebrahim Delpassand, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center Website
Other Identifiers
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MDA-ID-01538
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000355838
Identifier Type: REGISTRY
Identifier Source: secondary_id
ID01-538
Identifier Type: -
Identifier Source: org_study_id