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

NCT ID: NCT03861221

Last Updated: 2021-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-12-31

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.

Conditions

The Clinical Application Guide of Conebeam Breast CT

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Conebeam Breast Computed Tomography

Group Type: EXPERIMENTAL

CBBCT

Intervention Type: DEVICE

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

Interventions

CBBCT

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

Guangxi Medical University

OTHER

Sponsor Role: collaborator

Koning Corporation

INDUSTRY

Sponsor Role: collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhaoxiang Ye, M.D. & Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Locations

Tianjin Medical University Cancer Institute And Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

CBBCT2018CIH

Identifier Type: -

Identifier Source: org_study_id