NCT00972413

Cone Beam Computed Tomography for Breast Imaging

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Koning Corporation · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Computed Tomography	In Group I, twelve 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.
RADIATION	Computed Tomography	In Group II , at least fifty (50) study participants, who are categorized as BI-RADS® 4, 5 based on prior diagnostic work-up and are also scheduled for breast biopsy of a lesion, will undergo a breast CBCT specifically designed to image the breast.
RADIATION	Computed Tomography	In Group III, at least 30 study subjects, who are categorized as BI-RADS® 4, 5 based on prior diagnostic work-up and are also scheduled for breast biopsy of a lesion, will undergo a unilateral intravenous (IV) CE CBCT of the involved breast.

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-01-01
• Completion: 2012-05-01
• First posted: 2009-09-07
• Last updated: 2012-12-17

Locations

1 site across 1 country: United States