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Clinical Trials/NCT06497023
NCT06497023
Completed
Not Applicable

Multi-modality Radiomics Diagnostic Model Based on DCE-MRI and Ultrasound Images for Benign and Malignant Breast Lesion Classification

Ma Zhe1 site in 1 country550 target enrollmentJanuary 1, 2018
ConditionsBreast Diseases

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Diseases
Sponsor
Ma Zhe
Enrollment
550
Locations
1
Primary Endpoint
Accuracy of different diagnostic models
Status
Completed
Last Updated
last year

Overview

Brief Summary

To develop and compare multi-modality radiomics models based on DCE-MRI, B-mode ultrasound (BMUS) and strain elastography (SE) images for classifying benign and malignant breast lesions.

Detailed Description

In this retrospective study,555 breast lesions from 555 patients who underwent DCE-MRI, BMUS and SE examinations were randomly divided into training (n =388) and testing (n = 167) datasets. Radiomics features were extracted from manually contoured images. The inter-class correlation coefficient (ICC), Mann-Whitney U test and the least absolute shrinkage and selection operator (LASSO) regression was applied for feature selection and radiomics signature building.Nine radiomics models including four single-modality radiomics models (DCE-3D, DCE-2D, BMUS, and SE), four multi-modality radiomics models (BMUS + SE, DCE-3D + BMUS, DCE-3D + SE, and DCE-3D+SE+BMUS), and the combination diagnostic model(clinical features and DCE-3D+SE+BMUS features) were developed and evaluated by their discrimination, calibration, and clinical usefulness.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
March 30, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Ma Zhe
Responsible Party
Sponsor Investigator
Principal Investigator

Ma Zhe

Director of Ultrasound

Qianfoshan Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with breast lesions underwent biopsy or surgical resection between January 1, 2018 and March 30, 2024.

Exclusion Criteria

  • pathologicalresult of biopsy or surgical specimen was unavailable for the target lesion;
  • patients without DCE-MRI, BMUS and SE examinations before biopsy or surgery within one month;
  • patients hadperformed radiotherapy, chemotherapy, or breast biopsy before MRI and ultrasound examinations;
  • patients without completeDICOM data for each examination;
  • patients with poor-qualityimages.

Outcomes

Primary Outcomes

Accuracy of different diagnostic models

Time Frame: Immediately evaluated after the radiomcis diagnostic model was built

The accuracy of nine diagnostic models, including four single-modality radiomics models (DCE-3D, DCE-2D, BMUS, and SE), four multi-modality radiomics models (BMUS + SE, DCE-3D + BMUS, DCE-3D + SE, and DCE-3D+SE+BMUS),and the combination diagnostic model is the ratio of the sum of True Positive and True Negative to the total of True Positive, True Negative, False Positive, and False Negative.

Secondary Outcomes

  • Sensitivity of different diagnostic models(Immediately evaluated after the radiomcis diagnostic model was built)

Study Sites (1)

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