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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Shandong Cancer Hospital and Institute
Sponsor:
Information provided by (Responsible Party):
Yongsheng Wang, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier:
NCT01642511
First received: July 11, 2012
Last updated: August 24, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Radiation: 99mTc-labeled Sulfur Colloid
Procedure: Axillary Sentinel Lymph Node Biopsy
Drug: Methylthioninium
Device: Lymphoscintigraphy
Procedure: Axillary Lymph Node Dissection
Procedure: Internal Mammary Sentinel Lymph Node Biopsy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase II Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative

Resource links provided by NLM:


Further study details as provided by Shandong Cancer Hospital and Institute:

Primary Outcome Measures:
  • Visualization rate of IMSLN [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Visualization rate of IMSLN between conventional and modified techniques


Secondary Outcome Measures:
  • Metastasis Rate of IMSLN [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Metastasis rate of IMSLN in clinically axillary node-negative patients with IM-SLNB

  • Frequency and Severity of Complications with IM-SLNB [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Success rate of IM-SLNB [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 4
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Group
conventional technique: 99mTc-labeled Sulfur Colloid was injected into the tumor quadrant.
Radiation: 99mTc-labeled Sulfur Colloid
Each patient received the 1 intraparenchymal injection of 99mTc-SC (0.5~1.0 mCi/0.5mL) in the tumor quadrant.
Other Name: 99mTc-SC
Procedure: Axillary Sentinel Lymph Node Biopsy
Sentinel lymph node biopsy
Other Name: SLNB
Drug: Methylthioninium
Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery
Other Name: methylthioninium
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 Name: LSG
Procedure: Axillary Lymph Node Dissection
ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.
Other Name: ALND
Procedure: Internal Mammary Sentinel Lymph Node Biopsy
Internal mammary sentinel lymph node biopsy
Other Name: IM-SLNB
Experimental: Study Group
modified technique: 99mTc-labeled Sulfur Colloid was injected into 2 quadrants of the breast.
Radiation: 99mTc-labeled Sulfur Colloid
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 Name: 99mTc-SC
Procedure: Axillary Sentinel Lymph Node Biopsy
Sentinel lymph node biopsy
Other Name: SLNB
Drug: Methylthioninium
Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery
Other Name: methylthioninium
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 Name: LSG
Procedure: Axillary Lymph Node Dissection
ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.
Other Name: ALND
Procedure: Internal Mammary Sentinel Lymph Node Biopsy
Internal mammary sentinel lymph node biopsy
Other Name: IM-SLNB

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary breast cancer
  • clinically axilla-negative

Exclusion Criteria:

  • enlarged internal mammary nodes by imaging
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642511

Contacts
Contact: Yong-sheng Wang, MD +8613505409989 wangysh2008@yahoo.com.cn
Contact: Peng-fei Qiu, MD +8615168872002 qiupengfei2002@yahoo.cn

Locations
China, Shandong
Shandong Cancer Hospital Recruiting
Jinan, Shandong, China, 250117
Contact: Yong-sheng Wang, MD    +8613505409989    wangysh2008@yahoo.com.cn   
Contact: Peng-fei Qiu    +8615168872002    qiupengfei2002@yahoo.cn   
Principal Investigator: Yong-sheng Wang, MD         
Principal Investigator: Peng-fei Qiu, MD         
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Investigators
Study Chair: Yong-sheng Wang, MD Shandong Cancer Hospital
Principal Investigator: Peng-fei Qiu, MD Shandong Cancer Hospital
  More Information

Publications:
Responsible Party: Yongsheng Wang, Director, Head of Breast Cancer Center, Principal Investigator, Clinical Professor, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT01642511     History of Changes
Other Study ID Numbers: IMSN001
Study First Received: July 11, 2012
Last Updated: August 24, 2013
Health Authority: China: Ministry of Health

Keywords provided by Shandong Cancer Hospital and Institute:
Breast Cancer
Sentinel Lymph Node Biopsy
Internal Mammary
Lymphoscintigraphy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 26, 2014