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
  Purpose

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.


Condition Intervention
Breast Cancer
Drug: Isosulfan Blue
Procedure: Lymphangiography
Radiation: Technetium Tc 99m sulfur colloid

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Enrollment: 74
Study Start Date: June 2005
Study Completion Date: April 2008
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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.


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 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00438477

Locations
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Gildy V. Babiera, MD M.D. Anderson Cancer Center
Study Chair: Ebrahim Delpassand, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00438477     History of Changes
Other Study ID Numbers: ID01-538, P30CA016672, MDA-ID-01538, CDR0000355838
Study First Received: February 20, 2007
Last Updated: July 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
recurrent breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Technetium Tc 99m Sulfur Colloid
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014