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Koning Breast CT for Breast Imaging in China

NCT01792999 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 418

Last updated 2018-03-07

No results posted yet for this study

Summary

This study is conducted to compare Koning Breast CT (KBCT) to mammography to evaluate if KBCT can improve the diagnostic accuracy of breast cancer. It will also compare contrast-enhanced KBCT (CE-KBCT) to mammography to evaluate if CE-KBCT can further improve the diagnostic accuracy of breast cancer.

Conditions

Interventions

DEVICE

Contrast-enhanced KBCT

Contrast-enhanced KBCT includes pre-contrast KBCT scan and post-contrast KBCT scan. After the pre contrast scan is completed, a bolus injection of a low osmolar, nonionic, iodinated 300mg of iodine per mL contrast agent, will be injected at a rate of approximately 2.0 mL/s, for a total injection time of approximately 30-60 seconds. 30-60 seconds after the contrast injection, the post-contrast scan will be acquired.

Sponsors & Collaborators

  • Koning (Tianjin) Medical Equipment Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Zhaoxiang Ye, MD, PhD · Tianjin Medical University Cancer Institute and Hospital

  • Peihong Wu, MD · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01792999 on ClinicalTrials.gov