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| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
| Chinese PLA General Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Guangxi Medical University |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conebeam Breast Computed Tomography | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBBCT | Device | To compare the differences between various lesions' presentation on CBBCT and on other approaches under diverse breast conditions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standardize the routine scanning and application criteria of CBBCT. | 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. | Finish data acquisition and analysis, issue the standardized scanning protocol. Estimated duration: 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Summarize the breast anatomic features and lesions' characteristics on CBBCT. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Lymphoma patients that under therapy. Severe scoliosis.
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| Name | Affiliation | Role |
|---|---|---|
| Zhaoxiang Ye, M.D. & Ph.D. | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute And Hospital | Tianjin | Tianjin Municipality | 300060 | China |
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| OTHER |
| Koning Corporation | INDUSTRY |
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