Back to results

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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Isosulfan Blue

Lymphangiography

Technetium Tc 99m sulfur colloid

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage II breast cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must have either pathologic, radiologic or clinical evidence of breast cancer with invasion, suspicious for invasion or microinvasion.
Patients who are candidates for a total mastectomy or segmental mastectomy or axillary dissection.
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.
Patients must sign an informed consent and be registered before the procedure is performed.

Exclusion Criteria:

A pregnancy test will be required preoperatively in women of childbearing potential and patients who are pregnant will be excluded from this study.
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.
Patients with known allergy to isosulfan blue dye or any related compounds.

Sites / Locations

M. D. Anderson Cancer Center at University of Texas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Injection Methods

Arm Description

One injection site with radioactive tracer intraparenchymal/peritumoral (around the tumor), and other subareolar (around the nipple)

Outcomes

Primary Outcome Measures

Lymphatic drainage patterns as determined by peritumoral and subareolar injections

Evaluate outcome descriptively.

Identification rate of sentinel nodes and negative predictive value associated with subareolar injection

Evaluate outcome descriptively.

Secondary Outcome Measures

Full Information

NCT ID

NCT00438477

First Posted

February 20, 2007

Last Updated

July 27, 2012

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00438477

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

June 2005 (undefined)

Primary Completion Date

August 2006 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage II breast cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Injection Methods

Arm Type

Experimental

Arm Description

One injection site with radioactive tracer intraparenchymal/peritumoral (around the tumor), and other subareolar (around the nipple)

Intervention Type

Drug

Intervention Name(s)

Isosulfan Blue

Other Intervention Name(s)

lymphazurin

Intervention Description

At time of surgery, breast injected with 3-5 cc of isosulfan blue in subareolar or peritumoral position.

Intervention Type

Procedure

Intervention Name(s)

Lymphangiography

Intervention Description

2 lymphoscintigraphy images performed following peritumoral and subareolar injection of breast

Intervention Type

Radiation

Intervention Name(s)

Technetium Tc 99m sulfur colloid

Intervention Description

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.

Primary Outcome Measure Information:

Title

Lymphatic drainage patterns as determined by peritumoral and subareolar injections

Description

Evaluate outcome descriptively.

Time Frame

12 months to collect data

Title

Identification rate of sentinel nodes and negative predictive value associated with subareolar injection

Description

Evaluate outcome descriptively.

Time Frame

12 months to collecte data

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must have either pathologic, radiologic or clinical evidence of breast cancer with invasion, suspicious for invasion or microinvasion. Patients who are candidates for a total mastectomy or segmental mastectomy or axillary dissection. 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. Patients must sign an informed consent and be registered before the procedure is performed. Exclusion Criteria: A pregnancy test will be required preoperatively in women of childbearing potential and patients who are pregnant will be excluded from this study. 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. Patients with known allergy to isosulfan blue dye or any related compounds.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gildy V. Babiera, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ebrahim Delpassand, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

M. D. Anderson Cancer Center at University of Texas

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-4009

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

UT MD Anderson Cancer Center Website

Learn more about this trial

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

We'll reach out to this number within 24 hrs