Clinical trial · Observational
Ultrasound-Guided Core Needle Biopsy to Assess Sensitivity and Specificity of Axillary Lymph Node Metastasis in Breast Cancer
Sensitivity and Specificity of Ultrasound-Guided Core Needle Biopsy in Evaluating Axillary Lymph Node Metastasis in Breast Cancer
NCT07573657CI-TRIAL-00110712not yet recruitingClinicalTrials.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)
This study plans to find the most suitable lymph node cortex thickness and abnormal lymph node features to define suspicious lymph nodes. Then, ultrasound-guided core needle biopsy of axillary lymph nodes will be done, aiming to provide some guidance for the biopsy.
Conditions
Conditions (2)
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Lymphatic Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum cortical thickness of the lymph node (mm)
- timeFrame
- Measurements should be performed prior to treatment initiation, with a time interval not exceeding 4 weeks between the measurement and pathological examination.
- description
- The maximum thickness of the lymph node's cortical layer. Measured via conventional ultrasound examination of the lymph node's long-axis cross-section, perpendicular to the capsule surface, determining the maximum distance from the capsule to the corticomedullary junction.
Secondary outcomes (5)
- measure
- Age
- timeFrame
- Baseline
- description
- Age of participants at the time of initial diagnosis of primary breast cancer, reported in years.
- measure
- Menstrual Status
- timeFrame
- At initial diagnosis of primary breast cancer
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years and \<70 years; 2. Histologically confirmed primary breast cancer; 3. Underwent ultrasound examination to assess axillary lymph node metastasis status. Exclusion Criteria: 1. Presence of other malignancies (e.g., lymphoma, lung cancer, thyroid cancer, etc., with axillary metastasis); 2. Pregnant or lactating women; 3. Previous receipt of neoadjuvant radiotherapy or chemotherapy; 4. Lymph node metastasis status not confirmed by pathology, or time interval between ultrasound examination and pathological confirmation exceeding 6 weeks.
References
Publications (0)
Data not yet available
No reference posted for this study.