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NCT04929054 Clinical Trial

PCR Based CEUS in BI RADS 4A Nodules

Breast Cancer Clinical Trial

Official title:
Principal Component Regression Based Contrast Enhanced Ultrasound Evaluating System in the Management of BI-RADS 4A Breast Nodules

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04929054
Other study ID # Breast 2019
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date December 30, 2021

Study information
Verified date March 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study was to investigate the added value of Principal Component Regression (PCR) based contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS).

Description:

The aim of this study was to investigate the added value of Principal Component Regression (PCR) based contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS). The study included patients with 4A nodules confirmed by core biopsy and/or surgery. The CEUS parameters were assessed and PCR scores were calculated to evaluated the added value in BI-RADS 4A nodules.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 260
Est. completion date December 30, 2021
Est. primary completion date May 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: patients with BI-RADS 4A breast lesion Exclusion Criteria: (i) absence of a pathologic diagnosis; (ii) presence of breast nodules that were too large to compare with normal parenchyma; (iii) patients with radiotherapy and chemotherapy of breast cancer; and (iv) skin disorders.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• imaging
ultrasound and contrast enhanced ultrasound for BI RADS4A breast modules

Locations
Country Name City State
China SAHZJU Hanzhou Zhejiang

Sponsors (2)
Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary surgery or biopsy According to the PCR result, if it's positive, the nodule category was maintained, however, if it's negative, the nodule was downgraded. all nodules were submitted to biopsy or biopsy. up to 3 months
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