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NCT Number: NCT01668914

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

In addition to the axillary lymph nodes, the internal mammary lymph nodes (IMLNs) drainage is another important lymphatic channel of the breast. The status of IMLNs also provides important prognostic information for breast cancer patients. The technical evolvements of sentinel lymph node biopsy (SLNB) and lymphoscintigraphy provided a less invasive method for assessing IMLNs than surgical dissection. Recently, many study concerning IMSLNB was performed in the patients with clinically negative axillary nodes. However, previous published studies concerning patients with breast cancer who all underwent a radical mastectomy have shown that IMLN metastases are mostly found concomitantly with axillary metastases. For this reason, IM-SLNB is even more important for clinically axillary node-negative patients. To our knowledge, this is the first attempt of the IM-SLNB in early breast cancer patients with clinically positive axillary nodes.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

About this study

OBJECTIVES:

  • Determine the impact of routinely performed internal mammary sentinel lymph node biopsy on the systemic and locoregional treatments plan.
  • Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with clinically axillary node-positive.
  • Draw the learning curve of internal mammary sentinel lymph node biopsy.

OUTLINE:

3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-labeled sulfur colloid in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, lymphoscintigraphy is performed 0.5~1.0 hour before surgery. internal mammary sentinel lymph node biopsy is performed during the surgery and the internal mammary sentinel lymph nodes were sent to histologic examination.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primary breast cancer
  • clinically axilla-positive

Exclusion criteria

  • enlarged internal mammary nodes by imaging

Treatment and study plan

IM-SLNB

Procedure

IM-SLNB is performed according to the pre-operative lymphoscintigraphy

Other names: Internal Mammary Sentinel Lymph Node Biopsy

99mTc-SC

Radiation

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.

Other names: 99mTc-labeled Sulfur Colloid

Histologic Examination

Device

All IMSLNs were analyzed by histologic examination for future therapy planning.

Other names: hematoxylin-eosin staining and immunohistochemistry

LSG

Device

lymphoscintigraphy was performed 0.5~1.0 hour before surgery

Other names: Lymphoscintigraphy

Methylthioninium

Drug

Four milliliters of methylthioninium was injected intraparenchymally around the primary tumor 10 min before surgery

Primary outcomes

  1. Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB

    Time frame: 1 year

    Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB

Secondary outcomes

  1. Visualization Rate of IMSLNs

    Time frame: 1 year

    visualization rate of internal mammary hotspots in lymphoscintigraphy

  2. Metastasis Rate of IMSLNs

    Time frame: 1 year

    Metastasis Rate of internal mammary sentinel lymph node

Sponsors and collaborators

Lead sponsor

Shandong Cancer Hospital and Institute

Other

Registry information

Official study title

Phase III Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive

Acronym: IMSLNB-CANP

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 20, 2012
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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