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

NCT ID: NCT06497023

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 550 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2024-03-30

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.

Conditions

Breast Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

maligant

female patients with maligant breast masses who underwent biopsy and/or surgical resection.

No interventions assigned to this group

benign

female patients with benign breast masses who underwent biopsy and/or surgical resection.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ma Zhe

OTHER

Sponsor Role: lead

Responsible Party

Ma Zhe

Director of Ultrasound

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

QianfoshanH

Jinan, Shandong, China

Countries

China

Other Identifiers

YXLL-KY-2024(055)

Identifier Type: -

Identifier Source: org_study_id