The Clinical Application Guide of Conebeam Breast CT
Conditions
Brief summary
This study intends to recruit about 800 volunteers with 400 malignant cases and 400 benign cases (negative results included). The information acquired from those cases mainly includes: image acquirement parameters, physical examination data of patients, scanning positions, radiological images and diagnosis reports of CBBCT, mammography, breast ultrasound, MRI (if any), pathologic reports, follow-up reports and the like. The image quality comprehensive evaluation and multi-observer, multi-case diagnostic comparing experiment will be processed. With the pathologic report as gold standard, diagnostic comparing experiment between CBBCT and mammography, breast ultrasound, MRI will be designed to determine the differences between various lesions' presentation on CBBCT and on other approaches with diverse breast conditions (size, density). The problems to be solved in this study include: 1. Standardize the scanning positons, equipment parameter settings and other technical essentials based on the comprehensive analysis of image data acquisition, image quality and diverse patients' conditions, so as to guarantee image quality stability. 2. Summarize the breast anatomic features, typical and atypical lesions' characteristics on CBBCT image based on the analysis of 3D-CBBCT data and pathologic results as well as the comparing of CBBCT with other approaches, so as to establish the radiological diagnostic standard of CBBCT. 3. Standardize the application consensus of CBBCT based on the image features, data acquisition process and patients' conditions.
Interventions
DEVICECBBCT
To compare the differences between various lesions' presentation on CBBCT and on other approaches under diverse breast conditions.
Sponsors
Sun Yat-sen University
Chinese PLA General Hospital
The First Affiliated Hospital of Zhengzhou University
Guangxi Medical University
Koning Corporation
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female, older than 35 years. Already have mammography, or other standard exams (ultrasound, MRI, etc). Could participate this trial within 2 weeks after mammography. Have the ability of consent inform.
Exclusion criteria
* During pregnancy or lactation period. Patients that may not be capable of prone position, such as patients with scapulohumeral periarthritis, cardiac pacemaker or have recent cardiac surgery. Lymphoma patients that under therapy. Severe scoliosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardize the routine scanning and application criteria of CBBCT. | Finish data acquisition and analysis, issue the standardized scanning protocol. Estimated duration: 18 months. | Standardize the scanning positons, equipment parameter settings and other technical essentials based on the comprehensive analysis of image data acquisition, image quality and diverse patients' conditions; summarize the breast anatomic features, typical and atypical lesions' characteristics on CBBCT; standardize the application guidance of CBBCT based on the image features, data acquisition process and patients' conditions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Summarize the breast anatomic features and lesions' characteristics on CBBCT. | 1) Finish summarizing the anatomic features of breast on CBBCT. Estimated duration: 12 months. 2)Finish summarizing the typical and atypical lesions' characteristics on CBBCT. Estimated duration: 6 months from when anatomic features summary finished. | Summarize the breast anatomic features, typical and atypical lesions' characteristics on CBBCT image based on the analysis of 3D-CBBCT data and pathologic results as well as the comparing of CBBCT with other approaches, so as to establish the radiological diagnostic standard of CBBCT. |
Countries
China
Outcome results
None listed