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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00438477
First received: February 20, 2007
Last updated: July 27, 2012
Last verified: July 2012

February 20, 2007
July 27, 2012
June 2005
August 2006   (final data collection date for primary outcome measure)
  • 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.
  • Lymphatic drainage patterns as determined by peritumoral and subareolar injections
  • Identification rate of sentinel nodes and negative predictive value associated with subareolar injection
Complete list of historical versions of study NCT00438477 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Injection Methods in Finding the Sentinel Lymph Node During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Invasive Breast Cancer
A Preliminary Study To Explore Subareolar Injection As The Site For Lymphatic Mapping And Sentinel Lymph Node Biopsy In Patients With 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.

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 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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
  • Drug: Isosulfan Blue
    At time of surgery, breast injected with 3-5 cc of isosulfan blue in subareolar or peritumoral position.
    Other Name: lymphazurin
  • Procedure: Lymphangiography
    2 lymphoscintigraphy images performed following peritumoral and subareolar injection of breast
  • Radiation: 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.

Experimental: Injection Methods
One injection site with radioactive tracer intraparenchymal/peritumoral (around the tumor), and other subareolar (around the nipple)
Interventions:
  • Drug: Isosulfan Blue
  • Procedure: Lymphangiography
  • Radiation: Technetium Tc 99m sulfur colloid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
April 2008
August 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients must have either pathologic, radiologic or clinical evidence of breast cancer with invasion, suspicious for invasion or microinvasion.
  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:

  1. A pregnancy test will be required preoperatively in women of childbearing potential and patients who are pregnant will be excluded from this study.
  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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00438477
ID01-538, P30CA016672, MDA-ID-01538, CDR0000355838
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Gildy V. Babiera, MD M.D. Anderson Cancer Center
Study Chair: Ebrahim Delpassand, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP