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A Preliminary Study To Explore Subareolar Injection As The Site For Lymphatic Mapping And Sentinel Lymph Node Biopsy In Patients With Breast Cancer


N/A
N/A
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

A Preliminary Study To Explore Subareolar Injection As The Site For Lymphatic Mapping And Sentinel Lymph Node Biopsy In Patients With 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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Lymphatic drainage patterns as determined by peritumoral and subareolar injections

Outcome Description:

Evaluate outcome descriptively.

Outcome Time Frame:

12 months to collect data

Safety Issue:

No

Principal Investigator

Gildy V. Babiera, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID01-538

NCT ID:

NCT00438477

Start Date:

June 2005

Completion Date:

April 2008

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage II breast cancer
  • Breast Neoplasms

Name

Location

M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009