NCT03861221: CBBCT

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

Completed NA Last updated 29 October 2021

What this trial tests

NA trial testing CBBCT in The Clinical Application Guide of Conebeam Breast CT in 800 participants. Completed in 31 December 2020.

Timeline

1 January 2018

Primary endpoint
30 June 2019

31 December 2020

Quick facts

Lead sponsor	Tianjin Medical University Cancer Institute and Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	800
Start date	1 January 2018
Primary completion	30 June 2019
Estimated completion	31 December 2020
Sites	1 location across China

Drugs / interventions tested

• CBBCT

Conditions studied

• The Clinical Application Guide of Conebeam Breast CT — all drugs for The Clinical Application Guide of Conebeam Breast CT →

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Who can join

35 and older, female only, with The Clinical Application Guide of Conebeam Breast CT. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.