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Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer

NCT00450723 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-02-07

Study results available
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Summary

RATIONALE: Diagnostic procedures, such as thoracoscopic sentinel lymph node biopsy, may help find breast cancer that has spread to lymph nodes between the breasts. It may also help doctors plan the best treatment.

PURPOSE: This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy finds sentinel lymph nodes that are located between the breasts in patients with stage I or stage II breast cancer.

Conditions

Interventions

DRUG

Isosulfan blue

Administered pre-surgery; injection of 2 cc of Isosulfan Blue in four equal aliquots of 0.5 cc as routinely done for the axillary sentinel node procedure.

PROCEDURE

Axillary Lymph Node Dissection

Axillary Lymph Node Dissection

PROCEDURE

Surgery

The surgery will be performed under general anesthesia with a single lumen endo-tracheal tube. The patient will be laid in a semi decubitus position on the opposite side with the ipsilateral arm bent over the head and attached to an arm rest.

PROCEDURE

Sentinel Lymph Node Biopsy

Sentinel Lymph Node Biopsy

PROCEDURE

Thoracoscopic Surgery

Performed only if internal mammary sentinel node cannot be retrieved via same incision of lumpectomy/mastectomy.

RADIATION

Technetium Tc 99m Sulfur Colloid

Two to three hours prior to surgery, a peritumoral injection of filtered Technetium Sulfur Colloid will be performed in four 0.25 mci/2cc aliquots

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Eli Avisar, MD · University of Miami Sylvester Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2011-01-31
Completion
2011-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00450723 on ClinicalTrials.gov