Radiomics Model Based on DCE-MRI and Ultrasound Images for Breast Lesion Classification

Completed

• Conditions: Breast Diseases

• Registration Number: NCT06497023
• Lead Sponsor: Ma Zhe

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30
• Study First Submitted: 2024-06-23
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-03
• Last Update Submitted: 2024-07-03
• Study First Posted: 2024-07-11
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 550

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of different diagnostic models	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 Outcome Measures

Name	Time	Method
Sensitivity of different diagnostic models	Immediately evaluated after the radiomcis diagnostic model was built	The sensitivity of nine diagnostic models, four single-modality radiomics models (DCE-3D, DCE-2D, BMUS, and SE), including 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 True Positive to the sum of True Positive and False Negative.

Trial Locations

Locations (1)

QianfoshanH; 🇨🇳 Jinan, Shandong, China