Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Completed
NCT Number: NCT01642511
Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative
In addition to the axillary lymph node, the internal mammary lymph node (IMLN) chain is also the first-echelon nodal drainage site for metastasis and provides important prognostic information in breast cancer patients. The internal mammary sentinel lymph node biopsy (IM-SLNB) provides a less invasive method of assessing the IMLN than surgical dissection. But the low visualization rate of IMSLN has been a restriction of IM-SLNB. This clinical trial is carried out to improve the visualization rate of IMSLN with modified techniques: (1) The radiotracer is injected intraparenchymally into 2~4 quadrants of breast. (2) The radiotracer is injected in a high volume. (3) The radiotracer should be injected under ultrasonographic guidance.
Completed
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Notify MeKey information
Conditions
Age range
18 year–80 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 2
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- primary breast cancer
- clinically axilla-negative
Exclusion criteria
- enlarged internal mammary nodes by imaging
Treatment and study plan
99mTc-labeled Sulfur Colloid
RadiationControl 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: 99mTc-SC
Axillary Sentinel Lymph Node Biopsy
ProcedureSentinel lymph node biopsy
Other names: SLNB
Methylthioninium
DrugFour milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery
Lymphoscintigraphy
DeviceSequential 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: LSG
Axillary Lymph Node Dissection
ProcedureALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.
Other names: ALND
Internal Mammary Sentinel Lymph Node Biopsy
ProcedureInternal mammary sentinel lymph node biopsy
Other names: IM-SLNB
Primary outcomes
-
Visualization rate of IMSLN
Time frame: 1 year
Visualization rate of IMSLN between conventional and modified techniques
Secondary outcomes
-
Metastasis Rate of IMSLN
Time frame: 15 months
Metastasis rate of IMSLN in clinically axillary node-negative patients with IM-SLNB
-
Frequency and Severity of Complications with IM-SLNB
Time frame: 1 year
IM-SLNB complications in the patients who receive IM-SLNB
-
Success rate of IM-SLNB
Time frame: 1 year
Success rate of IM-SLNB in the IMSLN visualization patients who receive IM-SLNB
Sponsors and collaborators
Lead sponsor
Shandong Cancer Hospital and Institute
Other
Registry information
Official study title
Phase II Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative
Acronym: IMSLNB-EBCP
Important dates
- Study start
- 2012
- Primary completion
- 2014
- Study completion
- 2015
- First posted
- Jul 17, 2012
- Registry last updated
- Apr 4, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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