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Using Deep Learning and Radiomics to Diagnose Benign and Malignant Breast Lesions Based on Ultrasound

Ultrasound-based Deep Learning Signature and Radiomics Signature Nomogram for Diagnosis of Benign and Malignant Breast Lesions of BI-RADS Category 4 Using Intratumoral and Peritumoral Regions

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06069921
Enrollment
400
Registered
2023-10-06
Start date
2015-01-01
Completion date
2022-12-30
Last updated
2024-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Diseases

Brief summary

This retrospective study aimed to create a prediction model using deep learning and radiomics features extracted from intratumoral and peritumoral regions of breast lesions in ultrasound images, to diagnose benign and malignant breast lesions with BI-RADS 4 classification. Materials and methods: Patients who visited in The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital were collected. Their general clinical features, information on preoperative ultrasound diagnosis, and postoperative pathologic data were reviewed.

Interventions

None listed

Sponsors

Ma Zhe
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* female patients with US-visible solid breast masses who underwent biopsy and/or surgical resection, and were classified as having BI-RADS 4 lesions in medical US reports.

Exclusion criteria

* preoperative endocrine therapy, chemotherapy, or radiotherapy, preoperative invasive breast operation, insufficient image quality, and no pathological results.

Design outcomes

Primary

MeasureTime frameDescription
radiomcis prediction model and the model evaluationImmediately evaluated after the radiomcis prediction model was builtthree radiomics models were established using the support vector machines algorithm based on features extracted from the intratumoral, peritumoral, and combined regions of the breast lesions.The models were evaluated using various metrics, including AUC, accuracy, sensitivity, specificity, PPV, and NPV

Secondary

MeasureTime frameDescription
deep learning prediction model and the model evaluationImmediately evaluated after the deep learning prediction model was builtthree deep learning models were established using the support vector machines algorithm based on features extracted from the intratumoral, peritumoral, and combined regions of the breast lesions.The models were evaluated using various metrics, including AUC, accuracy, sensitivity, specificity, PPV, and NPV

Other

MeasureTime frameDescription
the combination prediction model and the model evaluationImmediately evaluated after the combination prediction model was builtthe combination model was established using clinical features , deep learning score and radiomics score.The models were evaluated using various metrics, including AUC, accuracy, sensitivity, specificity, PPV, and NPV

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026