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

NCT06497023 | Completed

• 1 other identifier: YXLL-KY-2024(055)
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Diseases

Outcome Measures

Primary Outcomes (1)

• Accuracy of different diagnostic models

  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.

  Immediately evaluated after the radiomcis diagnostic model was built

Secondary Outcomes (1)

• Sensitivity of different diagnostic models

  Immediately evaluated after the radiomcis diagnostic model was built

Other Outcomes (3)

• Specificity of different diagnostic models

  immediately evaluated after the combination diagnostic model was built

• PPV of different diagnostic models

  immediately evaluated after the combination diagnostic model was built

• NPV of different diagnostic models

  immediately evaluated after the combination diagnostic model was built

Study Arms (2)

maligant

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

benign

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

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast lesions attending the First Affiliated Hospital of Shandong First Medical University were selected

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ma Zhe: lead

Study Sites (1)

QianfoshanH

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Breast Diseases

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Ultrasound

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: July 11, 2024
• Study Start: January 1, 2018
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)