Clinical trial · Interventional
Selective Image Guided Resection of Axillary Lymph Nodes
Feasibility of Selective Image Guided Resection of Cytologically Documented Axillary Lymph Node Metastases
NCT01880645CI-TRIAL-00019840completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 goal of this clinical research study is to learn if it is feasible to use find (using ultrasound) and surgically remove cancer that has spread to the lymph nodes, during routine lymph node surgery. In standard care, all affected lymph nodes are removed. In this study, however, the cancerous lymph nodes will be removed separately and then the rest of the lymph nodes under the arm will be removed after that.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Surgery + Lymph Node Removal | Procedure | — | UNRESOLVED |
| Fine Needle Aspiration (FNA) | Procedure | — | UNRESOLVED |
| Ultrasound | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Ultrasound + Breast Surgery + Lymph Node Removal
- description
- Patient receives an ultrasound of lymph nodes at diagnosis and on the day of surgery. Marker clip(s) placed using a needle in the abnormal lymph node(s). If patient received chemotherapy before surgery, fine needle aspiration (FNA) performed of any abnormal lymph nodes either right before or during standard breast and underarm surgery. To perform FNA, area is numbed with anesthetic and a needle is inserted into the affected area so that cells can be collected. Standard breast and underarm surgery (underarm lymph node removal and either a partial mastectomy or total mastectomy with or without reconstruction) performed.
- interventionNames
- Procedure: Fine Needle Aspiration (FNA)
- Procedure: Ultrasound
- Procedure: Breast Surgery + Lymph Node Removal
Primary outcomes (1)
- measure
- Verification of Axillary Node Metastases Using Ultrasound Imaging Before and After Guided Excision
- timeFrame
- 1 day
- description
- Patients required to have a minimum of at least two nodal ultrasounds: once at diagnosis and once prior to surgery. Marker clip placed in the one or two abnormal node(s) at diagnosis and on day of surgery. Nodes localized by ultrasound (or by mammographic or 125I-seed localization if not visualized well with ultrasound) for excision, and fine needle aspiration (FNA) repeated of previous abnormal nodes. Patients undergo standard breast and axillary surgery. During surgery the one or two abnormal axillary nodes identified by ultrasound are removed. The lymph nodes excised with the clip will be evaluated with specimen x-ray. If no marker clip is identified in the lymph node(s), the axillary contents will be x-rayed to document removal of the marker clip. Procedure considered a success if all marker clips are successfully identified in the preoperative ultrasound and documented in a lymph node via postoperative specimen x-ray of the excised material.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Greater than or equal to 18 years old. 2. Histologic diagnosis of invasive breast cancer, clinical stage T0-3 N1 (maximum one or two abnormal axillary nodes on ultrasound exam) M0. 3. FNA biopsy (or core needle biopsy) of an axillary node documenting nodal disease at time of diagnosis and prior to preoperative chemotherapy or surgery. 4. Marker clip placed in the one or two abnormal axillary nodes identified at ultrasound. Exclusion Criteria: 1\) Prior axillary lymph node surgery for pathological confirmation of axillary status.
References
Publications (0)
Data not yet available
No reference posted for this study.