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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
IM-SLNB
99mTc-SC
Histologic Examination
LSG
Methylthioninium
Sponsored by
Shandong Cancer Hospital and Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer, Clinically Axillary Node -Positive, Sentinel Lymph Node Biopsy, Internal Mammary

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • primary breast cancer
  • clinically axilla-positive

Exclusion Criteria:

  • enlarged internal mammary nodes by imaging

Sites / Locations

  • Shandong Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

clinically positive axillary nodes

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB
Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB

Secondary Outcome Measures

Visualization Rate of IMSLNs
visualization rate of internal mammary hotspots in lymphoscintigraphy
Metastasis Rate of IMSLNs
Metastasis Rate of internal mammary sentinel lymph node

Full Information

First Posted
August 16, 2012
Last Updated
April 3, 2018
Sponsor
Shandong Cancer Hospital and Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01668914
Brief Title
Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive
Acronym
IMSLNB-CANP
Official Title
Phase III Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong Cancer Hospital and Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Clinically Axillary Node -Positive, Sentinel Lymph Node Biopsy, Internal Mammary

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
clinically positive axillary nodes
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
IM-SLNB
Other Intervention Name(s)
Internal Mammary Sentinel Lymph Node Biopsy
Intervention Description
IM-SLNB is performed according to the pre-operative lymphoscintigraphy
Intervention Type
Radiation
Intervention Name(s)
99mTc-SC
Other Intervention Name(s)
99mTc-labeled Sulfur Colloid
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Histologic Examination
Other Intervention Name(s)
hematoxylin-eosin staining and immunohistochemistry
Intervention Description
All IMSLNs were analyzed by histologic examination for future therapy planning.
Intervention Type
Device
Intervention Name(s)
LSG
Other Intervention Name(s)
Lymphoscintigraphy
Intervention Description
lymphoscintigraphy was performed 0.5~1.0 hour before surgery
Intervention Type
Drug
Intervention Name(s)
Methylthioninium
Intervention Description
Four milliliters of methylthioninium was injected intraparenchymally around the primary tumor 10 min before surgery
Primary Outcome Measure Information:
Title
Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB
Description
Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Visualization Rate of IMSLNs
Description
visualization rate of internal mammary hotspots in lymphoscintigraphy
Time Frame
1 year
Title
Metastasis Rate of IMSLNs
Description
Metastasis Rate of internal mammary sentinel lymph node
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary breast cancer clinically axilla-positive Exclusion Criteria: enlarged internal mammary nodes by imaging
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong-sheng Wang, MD
Organizational Affiliation
Shandong Cancer Hospital and Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peng-fei Qiu, MD
Organizational Affiliation
Shandong Cancer Hospital and Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yan-bing Liu, MD
Organizational Affiliation
Shandong Cancer Hospital and Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China

12. IPD Sharing Statement

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

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