Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative

PHASE2CompletedINTERVENTIONAL
Enrollment

407

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

November 30, 2014

Study Completion Date

March 31, 2015

Conditions
Breast Cancer
Interventions
RADIATION

99mTc-labeled Sulfur Colloid

Control Group: Each patient received the 1 intraparenchymal injection of 99mTc-SC (0.5\~1.0 mCi/0.5mL) in the tumor quadrant. Study Group: Two syringes of 0.25\~0.5 mCi 99mTc-SC in 0.2\~1.0 mL volume were injected intraparenchymally into 2 quadrants of breast, at the 6 and 12 o'clock positions.

PROCEDURE

Axillary Sentinel Lymph Node Biopsy

Sentinel lymph node biopsy

DRUG

Methylthioninium

Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery

DEVICE

Lymphoscintigraphy

Sequential anterior and lateral gamma imaging was performed with patients lying prone and by injection side just before surgery using a digital gamma camera computer system (Toshiba GCA-901A/HG).

PROCEDURE

Axillary Lymph Node Dissection

ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.

PROCEDURE

Internal Mammary Sentinel Lymph Node Biopsy

Internal mammary sentinel lymph node biopsy

Trial Locations (1)

250117

Shandong Cancer Hospital, Jinan

All Listed Sponsors
lead

Shandong Cancer Hospital and Institute

OTHER

NCT01642511 - Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative | Biotech Hunter | Biotech Hunter