Breast Cancer
Conditions
Keywords
Breast Cancer, Sentinel Lymph Node Biopsy, Internal Mammary, Lymphoscintigraphy
Brief summary
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.
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.
Interventions
RADIATION99mTc-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.
PROCEDUREAxillary Sentinel Lymph Node Biopsy
Sentinel lymph node biopsy
DRUGMethylthioninium
Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery
DEVICELymphoscintigraphy
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).
PROCEDUREAxillary Lymph Node Dissection
ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.
PROCEDUREInternal Mammary Sentinel Lymph Node Biopsy
Internal mammary sentinel lymph node biopsy
Sponsors
Shandong Cancer Hospital and Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* primary breast cancer * clinically axilla-negative
Exclusion criteria
* enlarged internal mammary nodes by imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visualization rate of IMSLN | 1 year | Visualization rate of IMSLN between conventional and modified techniques |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metastasis Rate of IMSLN | 15 months | Metastasis rate of IMSLN in clinically axillary node-negative patients with IM-SLNB |
| Frequency and Severity of Complications with IM-SLNB | 1 year | IM-SLNB complications in the patients who receive IM-SLNB |
| Success rate of IM-SLNB | 1 year | Success rate of IM-SLNB in the IMSLN visualization patients who receive IM-SLNB |
Countries
China
Outcome results
None listed