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

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

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.

Study Overview

• Status: Completed
• Conditions: The Clinical Application Guide of Conebeam Breast CT
• Intervention / Treatment: Device: CBBCT

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Conebeam Breast Computed Tomography	Device: CBBCT; To compare the differences between various lesions' presentation on CBBCT and on other approaches under diverse breast conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated Hospital of Zhengzhou University; Koning Corporation
• Investigators: Principal Investigator: Zhaoxiang Ye, M.D. & Ph.D., Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (ACTUAL): March 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CBBCT2018CIH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No