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

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:
NCT01668914
First received: August 16, 2012
Last updated: August 24, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Procedure: IM-SLNB
Radiation: 99mTc-SC
Device: Histologic Examination
Device: LSG
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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 -Positive

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Number of Participants Whose Systemic Treatment was Changed with IM-SLNB [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visualization Rate of IMSLNs [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    visualization rate of internal mammary hotspots in lymphoscintigraphy


Estimated Enrollment: 4
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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. 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 Name: 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 Name: 99mTc-labeled Sulfur Colloid
Device: Histologic Examination
All IMSLNs were analyzed by histologic examination for future therapy planning.
Other Name: hematoxylin-eosin staining and immunohistochemistry
Device: LSG
lymphoscintigraphy was performed 0.5~1.0 hour before surgery
Other Name: Lymphoscintigraphy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary breast cancer
  • clinically axilla-positive

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: NCT01668914

Contacts
Contact: Yong-sheng Wang, MD +8653167626211 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    +8653167626211    wangysh2008@yahoo.com.cn   
Contact: Peng-fei Qiu, MD    +8615168872002    qiupengfei2002@yahoo.cn   
Principal Investigator: Yong-sheng Wang, MD         
Principal Investigator: Peng-fei Qiu, MD         
Principal Investigator: Yan-bing Liu, 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
Principal Investigator: Yan-bing Liu, MD Shandong Cancer Hospital
  More Information

No publications provided

Responsible Party: Yongsheng Wang, Director, Head of Breast Cancer Center, Principal Investigator, Clinical Professor, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT01668914     History of Changes
Other Study ID Numbers: IMSN002
Study First Received: August 16, 2012
Last Updated: August 24, 2013
Health Authority: China: Ministry of Health

Keywords provided by Shandong Cancer Hospital and Institute:
Breast Cancer
Clinically Axillary Node -Positive
Sentinel Lymph Node Biopsy
Internal Mammary

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

ClinicalTrials.gov processed this record on July 23, 2014