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

Summary

In addition to the axillary lymph node, the internal mammary lymph node (IMLN) chain is also the first-echelon nodal drainage site for metastasis and provides important prognostic information in breast cancer patients. The internal mammary sentinel lymph node biopsy (IM-SLNB) provides a less invasive method of assessing the IMLN than surgical dissection. But the low visualization rate of IMSLN has been a restriction of IM-SLNB. This clinical trial is carried out to improve the visualization rate of IMSLN with modified techniques: (1) The radiotracer is injected intraparenchymally into 2\~4 quadrants of breast. (2) The radiotracer is injected in a high volume. (3) The radiotracer should be injected under ultrasonographic guidance.

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

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute

  lead OTHER

Principal Investigators

• Yong-sheng Wang, MD · Shandong Cancer Hospital and Institute

• Peng-fei Qiu, MD · Shandong Cancer Hospital and Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2014-11-30

Completion

2015-03-31

Countries

• China

Study Locations