- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01668914
Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive (IMSLNB-CANP)
Phase III Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250117
- Shandong Cancer Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- primary breast cancer
- clinically axilla-positive
Exclusion Criteria:
- enlarged internal mammary nodes by imaging
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
IM-SLNB is performed according to the pre-operative lymphoscintigraphy
Other Names:
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:
All IMSLNs were analyzed by histologic examination for future therapy planning.
Other Names:
lymphoscintigraphy was performed 0.5~1.0
hour before surgery
Other Names:
Four milliliters of methylthioninium was injected intraparenchymally around the primary tumor 10 min before surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visualization Rate of IMSLNs
Time Frame: 1 year
|
visualization rate of internal mammary hotspots in lymphoscintigraphy
|
1 year
|
Metastasis Rate of IMSLNs
Time Frame: 1 year
|
Metastasis Rate of internal mammary sentinel lymph node
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yan-bing Liu, MD, Shandong Cancer Hospital and Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMSN002
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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Clinical Trials on IM-SLNB
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Shandong Cancer Hospital and InstituteUnknown
-
Shandong Cancer Hospital and InstituteHenan Cancer Hospital; The Affiliated Hospital of Qingdao UniversityUnknown
-
Shandong Cancer Hospital and InstituteCompleted
-
Seoul National University HospitalNational Evidence-Based Healthcare Collaborating AgencyActive, not recruitingBreast Cancer | Sentinel Lymph NodeKorea, Republic of
-
The First Affiliated Hospital with Nanjing Medical...RecruitingBreast Cancer | Sentinel Lymph Node | Clinically Assessed Negative Axillary Lymph NodesChina
-
University of RostockGerman Breast Group; German Cancer AidActive, not recruitingBreast CancerAustria, Germany
-
Fudan UniversityRecruiting
-
Shengjing HospitalRecruiting
-
Toralf Reimer, MD PhDEuropean Breast Cancer Reseach Association of Surgical Trialists; University... and other collaboratorsRecruitingBreast Cancer | Breast Cancer FemaleSpain, Austria, Germany, Italy
-
National Cheng-Kung University HospitalActive, not recruitingBreast Cancer | Neoadjuvant Therapy | Sentinel Lymph Node BiopsyTaiwan