Prediction of Non-sentinel Lymph Node Metastatic Status of Breast Cancer Based on Pathology-MRI Images
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorYunnan Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
The investigators plan to retrospective collect 700 patients with breast cancer and prospective collect 150 patients with breast cancer
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Non-sentinel lymph node metastatic status
metastasis or non-metastasis
Time frame
2024-20252
Accuracy, Sensitivity, Specificity，Area under the curve
The performance of predicting non-sentinel lymph node metastatic status
Time frame
2024-20253
Positive predictive value，Negative predictive value
The performance of predicting non-sentinel lymph node metastatic status
Time frame
2024-2025Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yunnan Cancer Hospital
Lead sponsor
Affiliated Cancer Hospital of Shantou University Medical College
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: