Prediction of Non-sentinel Lymph Node Metastatic Status of Breast Cancer Based on Pathology-MRI Images

Not yet recruiting

• Conditions: Digital Pathology; Artificial Intelligence; Breast Cancer; Lymph Node Metastasis

• Registration Number: NCT06510738
• Lead Sponsor: Yunnan Cancer Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-14
• Study First Submitted QC: 2024-07-14
• Study First Posted: 2024-07-19
• Study Start: 2024-08
• Last Update Submitted: 2024-08-10
• Last Update Posted: 2024-08-13
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Non-sentinel lymph node metastatic status	2024-2025	metastasis or non-metastasis
Positive predictive value，Negative predictive value	2024-2025	The performance of predicting non-sentinel lymph node metastatic status
Accuracy, Sensitivity, Specificity，Area under the curve	2024-2025	The performance of predicting non-sentinel lymph node metastatic status