NCT01792999

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
418

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline
Completed

Started May 2012

Shorter than P25 for phase_3 breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

2.5 years

First QC Date

January 16, 2013

Last Update Submit

March 5, 2018

Conditions

Breast Cancer

Keywords

Breast CT

Outcome Measures

Primary Outcomes (1)

  • Efficacy of KBCT, CE-KBCT and Mammography

    Efficacy of KBCT, CE-KBCT and Mammography will be assessed based on the sensitivity for detecting breast cancer and the specificity for correctly categorizing non-cancer.

    1 year

Secondary Outcomes (1)

  • Safety of KBCT, CE-KBCT and Mammography

    1 year

Study Arms (2)

Non-contrast KBCT

NO INTERVENTION

About 187 subjects, who had diagnostic imaging of the breast including mammography and were categorized as Breast Imaging-Reporting and Data System(BIRADS) scores 1, 2, 3, 4, or 5, received KBCT imaging without contrast injection.

Contrast-enhanced KBCT

EXPERIMENTAL

About 231 subjects, who had diagnostic imaging of the breast including mammography and were scheduled for biopsy or surgery, received contrast-enhanced KBCT imaging of the affected breast before biopsy or surgery.

Device: Contrast-enhanced KBCT

Interventions

Contrast-enhanced KBCTDEVICE

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.

Contrast-enhanced KBCT

Eligibility Criteria

Age35 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females at least 35 years of age of any ethnicity
  • Had diagnostic imaging
  • Will undergo study imaging no later than two weeks from date of diagnostic mammogram
  • Is able to undergo informed consent

You may not qualify if:

  • Pregnancy
  • Lactation
  • Subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
  • Subjects who are unable to tolerate study constraints.
  • Subjects who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)
  • Treatment for enlarged thymus gland as an infant
  • Irradiation for benign breast conditions, including breast inflammation after giving birth
  • Treatment for Hodgkins disease
  • Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
  • Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
  • Tuberculosis
  • Severe scoliosis
  • Contrast-enhanced KBCT
  • Females at least 35 years of age of any ethnicity
  • Had diagnostic imaging and was determined to have biopsy or surgery
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Zhaoxiang Ye, MD, PhD

    Tianjin Medical University Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

  • Peihong Wu, MD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2013

First Posted

February 15, 2013

Study Start

May 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 7, 2018

Record last verified: 2018-03

Locations

CN(2)