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

Phase III Trail of 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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: IM-SLNB; Radiation: 99mTc-SC; Device: Histologic Examination; Device: LSG; Drug: Methylthioninium

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• primary breast cancer
• clinically axilla-positive

Exclusion Criteria:

• enlarged internal mammary nodes by imaging

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: clinically positive axillary nodes; 3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-SC in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, LSG is performed 0.5~1.0 hour before surgery. Methylthioninium was injected intraparenchymally. IM-SLNB is performed during the surgery and the IMSLNs were sent to histologic examination

Procedure: IM-SLNB; IM-SLNB is performed according to the pre-operative lymphoscintigraphy; Other Names: Internal Mammary Sentinel Lymph Node Biopsy; Radiation: 99mTc-SC; 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; Device: Histologic Examination; All IMSLNs were analyzed by histologic examination for future therapy planning.; Other Names: hematoxylin-eosin staining and immunohistochemistry; Device: LSG; lymphoscintigraphy was performed 0.5~1.0 hour before surgery; Other Names: Lymphoscintigraphy; Drug: Methylthioninium; Four milliliters of methylthioninium was injected intraparenchymally around the primary tumor 10 min before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB	Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visualization Rate of IMSLNs	visualization rate of internal mammary hotspots in lymphoscintigraphy	1 year
Metastasis Rate of IMSLNs	Metastasis Rate of internal mammary sentinel lymph node	1 year

Collaborators and Investigators

• Sponsor: Shandong Cancer Hospital and Institute
• Investigators: Principal Investigator: Yan-bing Liu, MD, Shandong Cancer Hospital And Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: August 16, 2012
• First Submitted That Met QC Criteria: August 16, 2012
• First Posted (Estimate): August 20, 2012

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Breast Cancer; Sentinel Lymph Node Biopsy; Internal Mammary; Clinically Axillary Node -Positive
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IMSN002