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

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.

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Key information

Conditions

Breast Cancer Artificial Intelligence Breast Diseases Breast Neoplasms Digital Pathology Lymph Node Metastasis Lymphatic Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with primary breast cancer
Positive sentinel lymph node biopsy and axillary lymph node dissection.
No neoadjuvant chemotherapy, radiotherapy or ablation prior to surgery.
MRI within 3 weeks prior to surgery.

Exclusion criteria

recurrent breast cancer or history of surgery or radiation therapy in the axilla
Inflammatory breast cancer
Bilateral breast cancer or metastatic breast cancer
previous or current history of other malignant tumors
Sentinel lymph node count > 5

Treatment and study plan

Primary outcomes

Non-sentinel lymph node metastatic status

Time frame: 2024-2025

metastasis or non-metastasis
Accuracy, Sensitivity, Specificity，Area under the curve

Time frame: 2024-2025

The performance of predicting non-sentinel lymph node metastatic status
Positive predictive value，Negative predictive value

Time frame: 2024-2025

The performance of predicting non-sentinel lymph node metastatic status

Sponsors and collaborators

Lead sponsor

Yunnan Cancer Hospital

Other

Collaborators

Affiliated Cancer Hospital of Shantou University Medical College

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 19, 2024
Registry last updated: Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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