- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01642511
Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative (IMSLNB-EBCP)
Phase II Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
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-negative
Exclusion Criteria:
- enlarged internal mammary nodes by imaging
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Group
conventional technique: 99mTc-labeled Sulfur Colloid was injected into the tumor quadrant 3-24 hours before surgery, lymphoscintigraphy was performed 30min before surgery.
Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery.
Axillary sentinel lymph node biopsy and Internal mammary sentinel lymph node biopsy was performed during surgery.
Axillary lymph node dissection was performed if ASLN was positive.
|
Control Group: Each patient received the 1 intraparenchymal injection of 99mTc-SC (0.5~1.0 mCi/0.5mL) in the tumor quadrant.
Study Group: 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:
Sentinel lymph node biopsy
Other Names:
Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery
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 Names:
ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.
Other Names:
Internal mammary sentinel lymph node biopsy
Other Names:
|
Experimental: Study Group
modified technique: 99mTc-labeled Sulfur Colloid was injected into 2 quadrants of the breast 3-24 hours before surgery, lymphoscintigraphy was performed 30min before surgery.
Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery.
Axillary sentinel lymph node biopsy and Internal mammary sentinel lymph node biopsy was performed during surgery.
Axillary lymph node dissection was performed if ASLN was positive.
|
Sentinel lymph node biopsy
Other Names:
Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery
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 Names:
ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.
Other Names:
Internal mammary sentinel lymph node biopsy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visualization rate of IMSLN
Time Frame: 1 year
|
Visualization rate of IMSLN between conventional and modified techniques
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metastasis Rate of IMSLN
Time Frame: 15 months
|
Metastasis rate of IMSLN in clinically axillary node-negative patients with IM-SLNB
|
15 months
|
Frequency and Severity of Complications with IM-SLNB
Time Frame: 1 year
|
IM-SLNB complications in the patients who receive IM-SLNB
|
1 year
|
Success rate of IM-SLNB
Time Frame: 1 year
|
Success rate of IM-SLNB in the IMSLN visualization patients who receive IM-SLNB
|
1 year
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Qiu PF, Liu JJ, Liu YB, Yang GR, Sun X, Wang YS. A modified technology could significantly improve the visualization rate of the internal mammary sentinel lymph nodes in breast cancer patients. Breast Cancer Res Treat. 2012 Nov;136(1):319-21. doi: 10.1007/s10549-012-2203-5. Epub 2012 Sep 6. No abstract available.
- Qiu P, Zhao R, Cong B, Yang G, Liu Y, Chen P, Sun X, Wang C, Wang Y. [Internal mammary sentinel lymph node biopsy in breast cancer: accurate staging and individualized treatment]. Zhonghua Zhong Liu Za Zhi. 2016 Jan;38(1):42-7. doi: 10.3760/cma.j.issn.0253-3766.2016.01.009. Chinese.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMSN001
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