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Clinical Trials/NCT05768451
NCT05768451
Not yet recruiting
Not Applicable

Accurate Prediction of Breast Cancer and Axillary Lymph Node Metastasis Burden by Multi-modal Ultrasound-based Radiomics

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School0 sites200 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Enrollment
200
Primary Endpoint
Accuracy of differential diagnosis between benign and malignant
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

The project is proposed based on multimodal ultrasonic imaging omics building used for accurate prediction of the breast cancer and axillary lymph node metastasis load artificial intelligence forecasting model, this method can dig the hidden features of ultrasonic image is not visible to the naked eye, make up the subjectivity in the process of clinical doctors in diagnosis and treatment, provide accurate, objective basis for clinical decision making.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
August 31, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients who have not received breast puncture biopsy or neoadjuvant chemotherapy, etc. prior to ultrasonography;
  • patients who are not allergic to the ultrasound contrast agent (SonoVue) and have signed an informed consent form for ultrasonography
  • patients with breast tumors who have undergone surgical treatment at our hospital and have complete case histories.

Exclusion Criteria

  • patients with incomplete case data;
  • cases with large breast masses that do not completely show the region of interest (ROI);
  • patients who have undergone breast aspiration biopsy or other treatments such as neoadjuvant chemotherapy or endocrine therapy before ultrasound examination.

Outcomes

Primary Outcomes

Accuracy of differential diagnosis between benign and malignant

Time Frame: 2022.12.15-2023.12.30

ROC curve, sensitivity, specificity, accuracy, decision curve

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