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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05768451
Other study ID # 2022-YXZX-YX-08
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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