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Ultrasound Radiomics for Predicting Breast Cancer and Axillary Lymph Node Metastasis

Accurate Prediction of Breast Cancer and Axillary Lymph Node Metastasis Burden by Multi-modal Ultrasound-based Radiomics

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05768451
Enrollment
200
Registered
2023-03-14
Start date
2023-04-01
Completion date
2025-08-31
Last updated
2023-03-14

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

Conditions

Axillary Lymph Node Metastasis, Breast Cancer

Keywords

breast cancer, multi-modal ultrasound, radiomics

Brief summary

The project is proposed based on multimodal ultrasonic imaging omics building used for accurate prediction of the breast cancer and axillary lymph node metastasis load artificial intelligence forecasting model, this method can dig the hidden features of ultrasonic image is not visible to the naked eye, make up the subjectivity in the process of clinical doctors in diagnosis and treatment, provide accurate, objective basis for clinical decision making.

Interventions

OTHERUltrasonic image analysis

Preoperative conventional ultrasound (US), elastic ultrasound (UE) and contrast-enhanced ultrasound (CEUS) images were analyzed. Histopathological results were used as the gold standard. The cases were randomly divided into training set and test set with a ratio of 7:3. The US image, UE image and CEUS image of the maximum long-axis section of each lesion were selected, and the region of interest (ROI) of the lesion was manually delineated.

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* patients who have not received breast puncture biopsy or neoadjuvant chemotherapy, etc. prior to ultrasonography; * patients who are not allergic to the ultrasound contrast agent (SonoVue) and have signed an informed consent form for ultrasonography * patients with breast tumors who have undergone surgical treatment at our hospital and have complete case histories.

Exclusion criteria

* patients with incomplete case data; * cases with large breast masses that do not completely show the region of interest (ROI); * patients who have undergone breast aspiration biopsy or other treatments such as neoadjuvant chemotherapy or endocrine therapy before ultrasound examination.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of differential diagnosis between benign and malignant2022.12.15-2023.12.30ROC curve, sensitivity, specificity, accuracy, decision curve

Contacts

Primary Contactbaojie wen, doctor
359408031@qq.com02583106666

Outcome results

None listed

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