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

April 2, 2018 updated by: Yongsheng Wang, Shandong Cancer Hospital and Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the visualization rate of internal mammary sentinel lymph node in breast cancer patients with different injection technologies.
  • Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with clinically axillary node -negative in these patients.
  • Evaluate the risk factors for internal mammary sentinel lymph node metastasis
  • Evaluate the success rate and the safety of internal mammary sentinel lymph node biopsy.
  • Draw the learning curve of internal mammary sentinel lymph node biopsy.

OUTLINE:

3~18 hours before surgery, 99mTc-labeled sulfur colloid was injected under ultrasonographic guidance in different patterns and injection methods were classified according to the number of injection quadrants. Subsequently, lymphoscintigraphy was performed 0.5~1.0 hour before surgery. During surgery, the sentinel lymph nodes (axillary or internal mammary) were identified by combining the use of intraoperative gamma detector and blue dye. The sentinel lymph nodes (axillary or internal mammary) were analyzed by hematoxylin-eosin staining and immunohistochemistry for future therapy planning.

Study Type

Interventional

Enrollment (Actual)

407

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • primary breast cancer
  • clinically axilla-negative

Exclusion Criteria:

  • enlarged internal mammary nodes by imaging

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
conventional technique: 99mTc-labeled Sulfur Colloid was injected into the tumor quadrant 3-24 hours before surgery, lymphoscintigraphy was performed 30min before surgery. Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery. Axillary sentinel lymph node biopsy and Internal mammary sentinel lymph node biopsy was performed during surgery. Axillary lymph node dissection was performed if ASLN was positive.
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.
Other Names:
  • 99mTc-SC
Procedure: Axillary Sentinel Lymph Node Biopsy
Sentinel lymph node biopsy
Other Names:
  • SLNB
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).
Other Names:
  • LSG
Procedure: Axillary Lymph Node Dissection
ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.
Other Names:
  • ALND
Procedure: Internal Mammary Sentinel Lymph Node Biopsy
Internal mammary sentinel lymph node biopsy
Other Names:
  • IM-SLNB
Experimental: Study Group
modified technique: 99mTc-labeled Sulfur Colloid was injected into 2 quadrants of the breast 3-24 hours before surgery, lymphoscintigraphy was performed 30min before surgery. Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery. Axillary sentinel lymph node biopsy and Internal mammary sentinel lymph node biopsy was performed during surgery. Axillary lymph node dissection was performed if ASLN was positive.
Procedure: Axillary Sentinel Lymph Node Biopsy
Sentinel lymph node biopsy
Other Names:
  • SLNB
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).
Other Names:
  • LSG
Procedure: Axillary Lymph Node Dissection
ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.
Other Names:
  • ALND
Procedure: Internal Mammary Sentinel Lymph Node Biopsy
Internal mammary sentinel lymph node biopsy
Other Names:
  • IM-SLNB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visualization rate of IMSLN
Time Frame: 1 year
Visualization rate of IMSLN between conventional and modified techniques
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metastasis Rate of IMSLN
Time Frame: 15 months
Metastasis rate of IMSLN in clinically axillary node-negative patients with IM-SLNB
15 months
Frequency and Severity of Complications with IM-SLNB
Time Frame: 1 year
IM-SLNB complications in the patients who receive IM-SLNB
1 year
Success rate of IM-SLNB
Time Frame: 1 year
Success rate of IM-SLNB in the IMSLN visualization patients who receive IM-SLNB
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Cancer Hospital and Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

July 11, 2012

First Submitted That Met QC Criteria

July 13, 2012

First Posted (Estimate)

July 17, 2012

Study Record Updates

Last Update Posted (Actual)

April 4, 2018

Last Update Submitted That Met QC Criteria

April 2, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMSN001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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