Cone Beam CT for Breast Imaging: A Pilot Study

Koning Corporation1 site in 1 country76 target enrollmentJuly 2006

ConditionsBreast Imaging Breast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Imaging
Sponsor: Koning Corporation
Enrollment: 76
Locations: 1
Primary Endpoint: Image Quality of Cone Beam Breast CT
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this pilot study is to investigate Cone Beam Computed Tomography Imaging (CBCT), with the primary goal, the accumulation of a body of evidence to provide preliminary data for a future extensive clinical trials.

Registry

clinicaltrials.gov

Start Date

July 2006

End Date

June 2012

Last Updated

12 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Koning Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Are at least 40 years of age of any ethnicity
•Had a routine mammogram, read as BI-RADS® 0, 1, 2 or 3
•Will undergo study imaging no later than six months from date of routine mammogram.
•Is able to undergo informed consent.

Exclusion Criteria

•Pregnancy
•Lactation
•Patients 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.
•Patients who are unable to tolerate study constraints.
•Patients 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 Hodgkin's disease
•Patients who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
•Patients who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)

Outcomes

Primary Outcomes

Image Quality of Cone Beam Breast CT

Time Frame: 6 years

This study was to evaluate the radiation dose, breast coverage, and image quality of cone-beam breast CT compared with a conventional mammographic examination.