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

Breast Disease Clinical Trial

Official title:

Correlation Between Multi-modal Ultrasound Features and Pathologic Classification of BI-RADS Category 4 Breast Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06025461
• Other study ID #: YXLL-KY-2023(012)
• Status: Completed
• Start date: November 15, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: August 2023
• Source: Qianfoshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 76 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Disease
• Breast Diseases

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	QianfoshanH	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Ma Zhe

Country where clinical trial is conducted

China, 

Outcome

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