Clinical trial · Interventional
Evaluation of Needle Core Biopsy of Axillary Sentinel Lymph Node in Breast Cancer
- 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)
The purpose of the study is to determine if it is possible to identify and perform a needle biopsy of the sentinel lymph node. The investigators hope to identify breast cancer cells in the lymph nodes under the arm without making an operation necessary. The rationale for this study is that for patients without enlarged lymph nodes under the arm, sentinel lymph node biopsy is the standard way of determining if breast cancer has spread to the lymph nodes under the arm. While the complications from a sentinel lymph node dissection are less than that of a complete axillary lymph node dissection, sentinel lymph node dissection still carries small risks of arm swelling, decreased movement, fluid collections, nerve injury, and pain. Furthermore, the majority of sentinel lymph nodes do not contain cancer. The investigators hope to develop a method to find cancer in the axillary lymph nodes and avoid the complications of an operation.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PNB of SLN | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PNB of SLN
- description
- Percutaneous core biopsy of sentinel node prior to standard sentinel node dissection
- interventionNames
- Procedure: PNB of SLN
Primary outcomes (1)
- measure
- Accuracy of axillary ultrasound guided percutaneous needle biopsy of sentinel node
- timeFrame
- 2 years
- description
- False positive and false negative rates of ultrasound guided needle biopsy of sentinel node will be determined by comparison of results with gold standard of open surgical sentinel node dissection.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer patients eligible for sentinel node dissection * Invasive ductal or invasive lobular carcinoma * Ductal carcinoma in situ undergoing total mastectomy * Clinically node-negative * 18-100 years Exclusion Criteria: * Inflammatory breast cancer * Pregnant or lactating * Preoperative chemotherapy * Prior axillary ultrasound guided core needle biopsy
References
Publications (1)
- DERIVEDPairawan SS, Cora C, Olaya W, Deisch J, Garberoglio R, Solomon N, Senthil M, Garberoglio C, Lum SS. Percutaneous Sentinel Node Biopsy in Breast Cancer: Results of a Phase 1 Study. Ann Surg Oncol. 2016 Oct;23(10):3330-6. doi: 10.1245/s10434-016-5320-2. Epub 2016 Jun 22. PMID 27334213