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

NCT03861221 | Completed

• 1 other identifier: CBBCT2018CIH
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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. 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. 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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.

Study Arms (1)

Conebeam Breast Computed Tomography

EXPERIMENTAL

Device: CBBCT

Interventions

CBBCT DEVICE

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

Conebeam Breast Computed Tomography

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Sun Yat-sen University: collaborator
• Chinese PLA General Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Guangxi Medical University: collaborator
• Koning Corporation: collaborator

Study Sites (1)

Tianjin Medical University Cancer Institute And Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Study Officials

• Zhaoxiang Ye, M.D. & Ph.D.

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: March 4, 2019
• Study Start: January 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2020
• Last Updated: October 29, 2021

Record last verified: 2018-06

Locations

CN (1)