Clinical trial · Interventional
Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative
Phase II Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 99mTc-labeled Sulfur Colloid | Radiation | — | UNRESOLVED |
| Axillary Lymph Node Dissection | Procedure | — | UNRESOLVED |
| Axillary Sentinel Lymph Node Biopsy | Procedure | — | UNRESOLVED |
| Internal Mammary Sentinel Lymph Node Biopsy | Procedure | — | UNRESOLVED |
| Lymphoscintigraphy | Device | — | UNRESOLVED |
| Methylthioninium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- 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.
- interventionNames
- Radiation: 99mTc-labeled Sulfur Colloid
- Procedure: Axillary Sentinel Lymph Node Biopsy
- Drug: Methylthioninium
- Device: Lymphoscintigraphy
- Procedure: Axillary Lymph Node Dissection
- Procedure: Internal Mammary Sentinel Lymph Node Biopsy
- type
- EXPERIMENTAL
- label
- Study Group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * primary breast cancer * clinically axilla-negative Exclusion Criteria: * enlarged internal mammary nodes by imaging
References
Publications (2)
- RESULTQiu 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. PMID 22956005
- DERIVEDQiu 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. PMID 26796806