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
1 other identifier
observational
85
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2023
CompletedFirst Submitted
Initial submission to the registry
August 30, 2023
CompletedFirst Posted
Study publicly available on registry
September 6, 2023
CompletedSeptember 6, 2023
August 1, 2023
1.4 years
August 30, 2023
August 30, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (5)
fibroadenoma group
breast hyperplasia group
other types of benign nodules group
non-specific invasive carcinoma group
other types of breast cancer group
Interventions
no intervention
Eligibility Criteria
Patients who visited in The First Affiliated Hospital of Shandong First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected.
You may qualify if:
- 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.
You may not qualify if:
- Poor image quality; Incomplete clinical data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ma Zhelead
Study Sites (1)
QianfoshanH
Shandong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Ultrasound
Study Record Dates
First Submitted
August 30, 2023
First Posted
September 6, 2023
Study Start
November 15, 2021
Primary Completion
March 30, 2023
Study Completion
March 30, 2023
Last Updated
September 6, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share