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Clinical Trials/NCT06510738
NCT06510738
Not yet recruiting
Not Applicable

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

Yunnan Cancer Hospital0 sites700 target enrollmentAugust 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Yunnan Cancer Hospital
Enrollment
700
Primary Endpoint
Non-sentinel lymph node metastatic status
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2024
End Date
December 2025
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Yunnan Cancer Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Non-sentinel lymph node metastatic status

Time Frame: 2024-2025

metastasis or non-metastasis

Positive predictive value,Negative predictive value

Time Frame: 2024-2025

The performance of predicting non-sentinel lymph node metastatic status

Accuracy, Sensitivity, Specificity,Area under the curve

Time Frame: 2024-2025

The performance of predicting non-sentinel lymph node metastatic status

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