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

• Sponsor: Ma Zhe (Other)
• Overall Status: Completed
• CT.gov ID: NCT06025461
• Collaborator: (none)
• Enrollment: 85
• Location: 1
• Actual Duration (Months): 16.4
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Disease	Other: no intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 85 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Correlation Between Multi-modal Ultrasound Features and Pathologic Classification of BI-RADS Category 4 Breast Lesions
• Actual Study Start Date: Nov 15, 2021
• Actual Primary Completion Date: Mar 30, 2023
• Actual Study Completion Date: Mar 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
fibroadenoma group	Other: no intervention; no intervention
breast hyperplasia group	Other: no intervention; no intervention
other types of benign nodules group	Other: no intervention; no intervention
non-specific invasive carcinoma group	Other: no intervention; no intervention
other types of breast cancer group	Other: no intervention; no intervention

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 76 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	QianfoshanH	Shandong		China

Sponsors and Collaborators

• Ma Zhe

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ma Zhe, Director of Ultrasound, Qianfoshan Hospital
• ClinicalTrials.gov Identifier: NCT06025461
• Other Study ID Numbers: YXLL-KY-2023(012)
• First Posted: Sep 6, 2023
• Last Update Posted: Sep 6, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Diseases

Study Results

No Results Posted as of Sep 6, 2023