Viewing Study NCT06497023



Ignite Creation Date: 2024-07-17 @ 11:31 AM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06497023
Status: COMPLETED
Last Update Posted: 2024-07-11
First Post: 2024-06-23

Brief Title: Radiomics Model Based on DCE-MRI and Ultrasound Images for Breast Lesion Classification
Sponsor: Ma Zhe
Organization: Qianfoshan Hospital

Study Overview

Official Title: Multi-modality Radiomics Diagnostic Model Based on DCE-MRI and Ultrasound Images for Benign and Malignant Breast Lesion Classification
Status: COMPLETED
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 study555 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 buildingNine 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-3DSEBMUS and the combination diagnostic modelclinical features and DCE-3DSEBMUS features were developed and evaluated by their discrimination calibration and clinical usefulness

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None