Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive
NCT ID: NCT01668914
Last Updated: 2018-04-05
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
PHASE3
126 participants
INTERVENTIONAL
2014-02-28
2017-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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
IM-SLNB is performed according to the pre-operative lymphoscintigraphy
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.
Histologic Examination
All IMSLNs were analyzed by histologic examination for future therapy planning.
LSG
lymphoscintigraphy was performed 0.5\~1.0 hour before surgery
Methylthioninium
Four milliliters of methylthioninium was injected intraparenchymally around the primary tumor 10 min before surgery
Interventions
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IM-SLNB
IM-SLNB is performed according to the pre-operative lymphoscintigraphy
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.
Histologic Examination
All IMSLNs were analyzed by histologic examination for future therapy planning.
LSG
lymphoscintigraphy was performed 0.5\~1.0 hour before surgery
Methylthioninium
Four milliliters of methylthioninium was injected intraparenchymally around the primary tumor 10 min before surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* clinically axilla-positive
Exclusion Criteria
18 Years
70 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
Yan-bing Liu, 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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Other Identifiers
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IMSN002
Identifier Type: -
Identifier Source: org_study_id
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