Clinical trial · Observational
Prediction of Non-sentinel Lymph Node Metastatic Status of Breast Cancer Based on Pathology-MRI Images
Prediction of Non-sentinel Lymph Node Metastatic Status of Breast Cancer Based on Pathology-MRI Images and Artificial Intelligence
- 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 observational study is to develop an artificial intelligence model based on pathology and magnetic resonance imaging (MRI) images to predict the metastatic status of non-sentinel lymph nodes in patients with breast cancer sentinel lymph node metastasis. The main questions it aims to answer are: Can an artificial intelligence model based on MRI images of breast cancer patients predict the non-sentinel lymph node metastatic status in patients with breast cancer sentinel lymph node metastasis? Can an artificial intelligence model based on intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastasis status in patients with sentinel lymph node metastasis from breast cancer? Can artificial intelligence models based on preoperative MRI and intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastatic status in patients with sentinel lymph node metastasis from breast cancer? Researchers will retrospectively and prospectively collect preoperative MRI and intraoperative sentinel lymph node section images from breast cancer patients.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Artificial Intelligence | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Digital Pathology | — | UNRESOLVED | — |
| Lymph Node Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Non-sentinel lymph node metastatic status
- timeFrame
- 2024-2025
- description
- metastasis or non-metastasis
- measure
- Accuracy, Sensitivity, Specificity,Area under the curve
- timeFrame
- 2024-2025
- description
- The performance of predicting non-sentinel lymph node metastatic status
- measure
- Positive predictive value,Negative predictive value
- timeFrame
- 2024-2025
- description
- The performance of predicting non-sentinel lymph node metastatic status
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with primary breast cancer 2. Positive sentinel lymph node biopsy and axillary lymph node dissection. 3. No neoadjuvant chemotherapy, radiotherapy or ablation prior to surgery. 4. MRI within 3 weeks prior to surgery. Exclusion Criteria: 1. recurrent breast cancer or history of surgery or radiation therapy in the axilla 2. Inflammatory breast cancer 3. Bilateral breast cancer or metastatic breast cancer 4. previous or current history of other malignant tumors 5. Sentinel lymph node count \> 5
References
Publications (0)
Data not yet available