Cone Beam Computed Tomography for Breast Imaging and IV Contrast Enhanced Cone Beam Computed Tomography Breast Imaging

Koning Corporation1 site in 1 country104 target enrollmentJune 2008

ConditionsBreast Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Koning Corporation
Enrollment: 104
Locations: 1
Primary Endpoint: The study's intent is to provide compelling data to illustrate the potential contribution of CBCT for breast imaging, not to generate statistically significant data.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary aim of this study is to investigate the use of cone beam computed tomography (CBCT) for breast imaging in the diagnostic setting by providing a compelling body of evidence incorporating both non-contrast and contrast enhanced CBCT in the study protocol. The goal is to accumulate a body of evidence to provide data to incorporate CBCT into the diagnostic work-up of breast lesions.

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

May 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

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 mammogram, read as BI-RADS® 1 or 2
•Will undergo study imaging no later than four weeks from date of mammogram.
•Is able to undergo informed consent.
•Are at least 40 years of age of any ethnicity
•Had a routine mammogram, read as BI-RADS® 4 or 5
•Are scheduled for breast biopsy
•Will undergo study imaging no later than four weeks from date of mammogram, prior to breast biopsy.
•Is able to undergo informed consent.
•Are at least 40 years of age of any ethnicity

Exclusion Criteria

•Group I and Group II:
•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.

Outcomes

Primary Outcomes

The study's intent is to provide compelling data to illustrate the potential contribution of CBCT for breast imaging, not to generate statistically significant data.

Time Frame: 3 years