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

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ClinicalTrials.gov Identifier: NCT01668914
Recruitment Status : Completed
First Posted : August 20, 2012
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Yongsheng Wang, Shandong Cancer Hospital and Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Procedure: IM-SLNB Radiation: 99mTc-SC Device: Histologic Examination Device: LSG Drug: Methylthioninium Phase 3

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  (Clinical Trial)
Actual Enrollment : 126 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase III Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive
Actual Study Start Date : February 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : December 2017

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U.S. FDA Resources

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668914


Locations
China, Shandong
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
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

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
First Posted: August 20, 2012    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Keywords provided by Yongsheng Wang, 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