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

NACompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

May 31, 2004

Primary Completion Date

January 31, 2011

Study Completion Date

March 31, 2011

Conditions
Breast Cancer
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

Trial Locations (1)

33136

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami

All Listed Sponsors
lead

University of Miami

OTHER

NCT00450723 - Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer | Biotech Hunter | Biotech Hunter