Multimodal Ultrasound Diagnosis Characteristics of Bi-rads Class 4 Breast Lesions

Completed

• Conditions: Breast Disease
• Interventions: Other: no intervention

• Registration Number: NCT06025461
• Lead Sponsor: Ma Zhe

Brief Summary

Objective: To explore the potential association between the multimodal ultrasound characteristics and pathological classification of BI-RADS category 4 breast lesions, so as to clarify the diagnostic characteristics of multimodal ultrasound in different pathological types BI-RADS category 4 breast lesions.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-15
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30
• Status Verified: 2023-08
• Study First Submitted: 2023-08-30
• Study First Submitted QC: 2023-08-30
• Last Update Submitted: 2023-08-30
• Study First Posted: 2023-09-06
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

Inclusion Criteria

• Perform ultrasound examination at our hospital before surgery or puncture biopsy; Complete histopathological data; Two ultrasound physicians with more than 5 years of experience in breast ultrasound diagnosis were diagnosed as BI-RADS Class 4 based on preoperative ultrasound images.

Exclusion Criteria

• Poor image quality; Incomplete clinical data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
fibroadenoma group	no intervention	-
other types of benign nodules group	no intervention	-
non-specific invasive carcinoma group	no intervention	-
other types of breast cancer group	no intervention	-
breast hyperplasia group	no intervention	-

Primary Outcome Measures

Name	Time	Method
elasticity imaging/B-mode ratio	Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography	The ratio of lesion length on strain elastography images to lesion length on grayscale images
strain ratio	Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography	The ratio of average strain between surrounding tissues at the same depth and the lesion
shear wave velocity	Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography	Shear wave velocity values at the hardest point of the lesion and surrounding tissues

Trial Locations

Locations (1)

QianfoshanH; 🇨🇳 Shandong, China