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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06025461

Enrollment

Registered

2023-09-06

Start date

2021-11-15

Completion date

2023-03-30

Last updated

2023-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Disease

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.

Interventions

OTHERno intervention

no intervention

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 76 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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
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
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026