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

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ClinicalTrials.gov Identifier: NCT00438477
Recruitment Status : Completed
First Posted : February 22, 2007
Last Update Posted : July 30, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Breast Cancer Drug: Isosulfan Blue Procedure: Lymphangiography Radiation: Technetium Tc 99m sulfur colloid Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Lymphatic drainage patterns as determined by peritumoral and subareolar injections [ Time Frame: 12 months to collect data ]
    Evaluate outcome descriptively.

  2. Identification rate of sentinel nodes and negative predictive value associated with subareolar injection [ Time Frame: 12 months to collecte data ]
    Evaluate outcome descriptively.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438477


Locations
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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
National Cancer Institute (NCI)
Investigators
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Study Chair: Gildy V. Babiera, MD M.D. Anderson Cancer Center
Study Chair: Ebrahim Delpassand, MD M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00438477    
Other Study ID Numbers: ID01-538
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-ID-01538 ( Other Identifier: UT MD Anderson Cancer Center )
CDR0000355838 ( Registry Identifier: NCI PDQ )
First Posted: February 22, 2007    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2012
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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Technetium Tc 99m Sulfur Colloid
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action