Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative
NCT ID: NCT01642511
Last Updated: 2018-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
407 participants
INTERVENTIONAL
2012-01-31
2015-03-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
99mTc-labeled Sulfur Colloid
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.
Axillary Sentinel Lymph Node Biopsy
Sentinel lymph node biopsy
Methylthioninium
Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery
Lymphoscintigraphy
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).
Axillary Lymph Node Dissection
ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.
Internal Mammary Sentinel Lymph Node Biopsy
Internal mammary sentinel lymph node biopsy
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.
Axillary Sentinel Lymph Node Biopsy
Sentinel lymph node biopsy
Methylthioninium
Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery
Lymphoscintigraphy
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).
Axillary Lymph Node Dissection
ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.
Internal Mammary Sentinel Lymph Node Biopsy
Internal mammary sentinel lymph node biopsy
Interventions
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99mTc-labeled Sulfur Colloid
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.
Axillary Sentinel Lymph Node Biopsy
Sentinel lymph node biopsy
Methylthioninium
Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery
Lymphoscintigraphy
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).
Axillary Lymph Node Dissection
ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.
Internal Mammary Sentinel Lymph Node Biopsy
Internal mammary sentinel lymph node biopsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* clinically axilla-negative
Exclusion Criteria
18 Years
80 Years
FEMALE
No
Sponsors
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Shandong Cancer Hospital and Institute
OTHER
Responsible Party
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Yongsheng Wang
Director, Head of Breast Cancer Center, Principal Investigator, Clinical Professor
Principal Investigators
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Yong-sheng Wang, MD
Role: STUDY_CHAIR
Shandong Cancer Hospital and Institute
Peng-fei Qiu, MD
Role: PRINCIPAL_INVESTIGATOR
Shandong Cancer Hospital and Institute
Locations
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Shandong Cancer Hospital
Jinan, Shandong, China
Countries
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References
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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.
Other Identifiers
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IMSN001
Identifier Type: -
Identifier Source: org_study_id
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