NCT01107860

Cone Beam Computed Tomography for Breast Imaging

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 401 (actual)
• Sponsor: Koning Corporation · Industry
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Accepted

Summary

The primary aim of this study is to continue the investigation of cone beam computed tomography (CBCT) for breast imaging already underway in the diagnostic setting by providing a compelling body of evidence incorporating non-contrast 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Computed Tomography	In Group I, fifty CBCT studies will be performed. The objectives will be to illustrate the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam.
DEVICE	Computed Tomography	In Group II , at least three hundred and fifty (350) study participants, who require diagnostic evaluation of the breast will undergo a breast CBCT . These subjects may be referred for biopsy as a result of a finding from a mammogram, ultrasound, MRI, or clinical exam.

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-12-01
• Completion: 2013-06-01
• First posted: 2010-04-21
• Last updated: 2013-06-18

Locations

1 site across 1 country: United States