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

T

Tianjin Medical University

Status

Completed

Conditions

The Clinical Application Guide of Conebeam Breast CT

Treatments

Device: CBBCT

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03861221
CBBCT2018CIH

Details and patient eligibility

About

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: 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. 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. Standardize the application consensus of CBBCT based on the image features, data acquisition process and patients' conditions.

Enrollment

800 patients

Sex

Female

Ages

35+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

800 participants in 1 patient group

Conebeam Breast Computed Tomography
Experimental group
Treatment:
Device: CBBCT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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