NCT03861221

The Technical Operations And Standard Clinical Application Protocol of CBBCT in Diagnostic Process of Breast Cancer

The Technical Operations And Standard Clinical Application Protocol of Cone Beam Breast CT in Diagnostic Process of Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• The Clinical Application Guide of Conebeam Breast CT

Interventions

Type	Name	Description
DEVICE	CBBCT	To compare the differences between various lesions' presentation on CBBCT and on other approaches under diverse breast conditions.

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-06-30
• Completion: 2020-12-31
• First posted: 2019-03-04
• Last updated: 2021-10-29

Locations

1 site across 1 country: China