Ultrasound Radiomics for Predicting Breast Cancer and Axillary Lymph Node Metastasis

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05768451
• Other study ID #: 2022-YXZX-YX-08
• Status: Not yet recruiting
• Start date: April 1, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: March 2023
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: baojie wen, doctor
• Phone: 02583106666
• Email: 359408031[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphatic Metastasis
• Neoplasm Metastasis

Intervention

Other:
• Ultrasonic 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of differential diagnosis between benign and malignant	ROC curve, sensitivity, specificity, accuracy, decision curve	2022.12.15-2023.12.30