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OpenTrials
Completed

NCT Number: NCT06025461

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

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.

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Key information

Age range

30 year–76 year

Sex eligibility

Female

Study type

Observational

Primary location

QianfoshanH

Shandong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. elasticity imaging/B-mode ratio

    Time frame: 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

  2. shear wave velocity

    Time frame: 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

  3. strain ratio

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ma Zhe

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2023
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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