PCR Based CEUS in BI RADS 4A Nodules
- Conditions
- PCABreast Cancer
- Registration Number
- NCT04929054
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief 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).
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 260
patients with BI-RADS 4A breast lesion
(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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method surgery or biopsy up to 3 months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
SAHZJU
🇨🇳Hanzhou, Zhejiang, China