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

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

DEVICE

CBBCT

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

Sponsors & Collaborators

• Sun Yat-sen University

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Guangxi Medical University

  collaborator OTHER

• Koning Corporation

  collaborator INDUSTRY

• Tianjin Medical University Cancer Institute and Hospital

  lead OTHER

Principal Investigators

• Zhaoxiang Ye, M.D. & Ph.D. · Tianjin Medical University Cancer Institute and Hospital

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

35 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-01-01

Primary Completion

2019-06-30

Completion

2020-12-31

Countries

• China

Study Locations