Cone Beam Computed Tomography for Breast Imaging

PHASE1CompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

January 31, 2010

Study Completion Date

May 31, 2012

Conditions
Breast Cancer
Interventions
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.

Trial Locations (1)

14620

Elizabeth Wende Breast Care, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Koning Corporation

INDUSTRY

NCT00972413 - Cone Beam Computed Tomography for Breast Imaging | Biotech Hunter | Biotech Hunter