Ultrasound Radiomics for Predicting Breast Cancer and Axillary Lymph Node Metastasis

Not yet recruiting

• Conditions: Axillary Lymph Node Metastasis; Breast Cancer
• Interventions: Other: Ultrasonic image analysis

• Registration Number: NCT05768451
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-05
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-13
• Last Update Submitted: 2023-03-13
• Study First Posted: 2023-03-14
• Last Update Posted: 2023-03-14
• Study Start: 2023-04-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
benign	Ultrasonic image analysis	-
malignant	Ultrasonic image analysis	-

Primary Outcome Measures

Name	Time	Method
Accuracy of differential diagnosis between benign and malignant	2022.12.15-2023.12.30	ROC curve, sensitivity, specificity, accuracy, decision curve